- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04622709
Pilot Study of Loop Diuretics Among Individuals Receiving Hemodialysis
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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North Carolina
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Carrboro, North Carolina, Stati Uniti, 27510
- Carolina Dialysis - Carrboro
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Pittsboro, North Carolina, Stati Uniti, 27312
- Carolina Dialysis - Pittsboro
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Sanford, North Carolina, Stati Uniti, 27330
- Carolina Dialysis - Sanford
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Sanford, North Carolina, Stati Uniti, 27332
- Carolina Dialysis - Lee County
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Siler City, North Carolina, Stati Uniti, 27344
- Carolina Dialysis - Siler City
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Patient self-report of at least 1 cup urine/24-hours
- Age ≥18 years
- Receipt of thrice weekly in-center HD at a participating clinic (UNC-associated Carolina Dialysis- Carrboro, Siler City, Pittsboro, Sanford, and Lee County)
- ≥60 days receiving in-center HD
- Willingness to take study medication and undergo study testing
- Ability to provide informed consent
Exclusion Criteria:
- Known allergy to loop diuretic
- History of poor adherence to HD or medical regimen per nephrologist
- >1 hospitalization in prior 30-days
- Frequent hypotension (systolic BP <80 mmHg at >30% of HD treatments in prior 30-days)
- Cirrhosis per nephrologist
- Hearing disorder per nephrologist
- Serum potassium <3.5 mEq/L, magnesium <1 mg/dL, or corrected calcium <8 mg/dL in prior 30-days
- Taking a non-loop diuretic (e.g. spironolactone, eplerenone, ethacrynic acid, thiazides)
- Taking an aminoglycoside, cisplatin, methotrexate, cyclosporine, adrenocorticotropic hormone (ACTH), lithium, phenytoin, or oral/intravenous steroid
- Natural licorice consumption
- Prisoners, patients with significant mental illness
- Pregnant patients and nursing mothers
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Study drug administration: furosemide
Study participants will receive furosemide oral tablets to be taken twice daily.
During study period 1 (first 6 weeks), the drug dose will be escalated every 2 weeks if safe, tolerated, and acceptable to the participant.
During study period 2 (subsequent 12 weeks), participants will take the maximum tolerated dose from study period 1, received every 4 weeks if safe, tolerated, and acceptable to the participant.
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Open label dose escalation study of furosemide in people receiving maintenance hemodialysis.
Participants will take furosemide oral tablets twice daily for 18 weeks.
Doses will be titrated every 2 weeks for 6 weeks if safe, effective, tolerated, and accepted by the participant.
First 2 weeks of the study: participants not taking oral furosemide at enrollment will take 80mg furosemide twice daily, those taking oral furosemide at enrollment will stay on their prescribed dose, and those taking another loop diuretic at enrollment will discontinue their prescription and take an equivalent oral furosemide dose.
At week 4: dose escalation if tolerated (from 80mg to 120mg twice daily for the 1st group, and a 50% increased dose not >320mg/day for the 2nd & 3rd groups).
At week 6: dose escalation if tolerated (from 120mg to 160mg twice daily for the 1st group, and a 50% increased dose not >320mg/day for the 2nd & 3rd groups).
Final 12 weeks: all participants will take the maximum tolerated dose.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Percentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 5
Lasso di tempo: Baseline and study week 5 (5 weeks after study medication start
|
Participants will follow standard dialysis clinic protocols for 24-urine volume collection. Classifying participants as has having an increase in 24-hour urine volume will be contingent on the amount of urine the participant makes at baseline.
The percentage of participants who have a defined increase in 24-urine volume from baseline to week 5 will be determined. |
Baseline and study week 5 (5 weeks after study medication start
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Percentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 12
Lasso di tempo: Baseline and study week 12 (12 weeks after study medication start)
|
Participants will follow standard dialysis clinic protocols for 24-urine volume collection. Classifying participants as has having an increase in 24-hour urine volume will be contingent on the amount of urine the participant makes at baseline.
The percentage of participants who have a defined increase in 24-urine volume from baseline to week 12 will be determined. |
Baseline and study week 12 (12 weeks after study medication start)
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Percentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 18
Lasso di tempo: Baseline and study week 18 (18 weeks after study medication start)
|
Participants will follow standard dialysis clinic protocols for 24-urine volume collection. Classifying participants as has having an increase in 24-hour urine volume will be contingent on the amount of urine the participant makes at baseline.
The percentage of participants who have a defined increase in 24-urine volume from baseline to week 18 will be determined. |
Baseline and study week 18 (18 weeks after study medication start)
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Percentage of Participants With A Serum Potassium <3.2 mEq/L at Week 1
Lasso di tempo: Study week 1 (1 week after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 1 study visit.
The percentage of participants who have a serum potassium <3.2 mEq/L will be determined.
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Study week 1 (1 week after study medication start)
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Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 2
Lasso di tempo: Study week 2 (2 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 2 study visit.
The percentage of participants who have a serum potassium <3.2 mEq/L will be determined.
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Study week 2 (2 weeks after study medication start)
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Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 3
Lasso di tempo: Study week 3 (3 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 3 study visit.
The percentage of participants who have a serum potassium <3.2 mEq/L will be determined.
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Study week 3 (3 weeks after study medication start)
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Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 4
Lasso di tempo: Study week 4 (4 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 4 study visit.
The percentage of participants who have a serum potassium <3.2 mEq/L will be determined.
|
Study week 4 (4 weeks after study medication start)
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Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 5
Lasso di tempo: Study week 5 (5 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 5 study visit.
The percentage of participants who have a serum potassium <3.2 mEq/L will be determined.
|
Study week 5 (5 weeks after study medication start)
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Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 6
Lasso di tempo: Study week 6 (6 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 6 study visit.
The percentage of participants who have a serum potassium <3.2 mEq/L will be determined.
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Study week 6 (6 weeks after study medication start)
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Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 9
Lasso di tempo: Study week 9 (9 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 9 study visit.
The percentage of participants who have a serum potassium <3.2 mEq/L will be determined.
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Study week 9 (9 weeks after study medication start)
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Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 13
Lasso di tempo: Study week 13 (13 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 13 study visit.
The percentage of participants who have a serum potassium <3.2 mEq/L will be determined.
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Study week 13 (13 weeks after study medication start)
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Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 17
Lasso di tempo: Study week 17 (17 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 17 study visit.
The percentage of participants who have a serum potassium <3.2 mEq/L will be determined.
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Study week 17 (17 weeks after study medication start)
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Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 1
Lasso di tempo: Study week 1 (1 week after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 1 study visit.
The percentage of participants who have a serum magnesium <0.8 mEq/L will be determined.
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Study week 1 (1 week after study medication start)
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Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 2
Lasso di tempo: Study week 2 (2 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 2 study visit.
The percentage of participants who have a serum magnesium <0.8 mEq/L will be determined.
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Study week 2 (2 weeks after study medication start)
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Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 3
Lasso di tempo: Study week 3 (3 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 3 study visit.
The percentage of participants who have a serum magnesium <0.8 mEq/L will be determined.
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Study week 3 (3 weeks after study medication start)
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Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 4
Lasso di tempo: Study week 4 (4 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 4 study visit.
The percentage of participants who have a serum magnesium <0.8 mEq/L will be determined.
|
Study week 4 (4 weeks after study medication start)
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Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 5
Lasso di tempo: Study week 5 (5 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 5 study visit.
The percentage of participants who have a serum magnesium <0.8 mEq/L will be determined.
|
Study week 5 (5 weeks after study medication start)
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Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 6
Lasso di tempo: Study week 6 (6 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 6 study visit.
The percentage of participants who have a serum magnesium <0.8 mEq/L will be determined.
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Study week 6 (6 weeks after study medication start)
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Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 9
Lasso di tempo: Study week 9 (9 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 9 study visit.
The percentage of participants who have a serum magnesium <0.8 mEq/L will be determined.
|
Study week 9 (9 weeks after study medication start)
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Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 13
Lasso di tempo: Study week 13 (13 weeks after study medication start)
|
Blood samples will be collected from participants prior to their dialysis treatments at the week 13 study visit.
The percentage of participants who have a serum magnesium <0.8 mEq/L will be determined.
|
Study week 13 (13 weeks after study medication start)
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Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 17
Lasso di tempo: Study week 17 (17 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 17 study visit.
The percentage of participants who have a serum magnesium <0.8 mEq/L will be determined.
|
Study week 17 (17 weeks after study medication start)
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Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 1
Lasso di tempo: Study week 1 (1 week after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 1 study visit.
The percentage of participants who have a serum corrected calcium <7.0 mg/dL will be determined.
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Study week 1 (1 week after study medication start)
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Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 2
Lasso di tempo: Study week 2 (2 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 2 study visit.
The percentage of participants who have a serum corrected calcium <7.0 mg/dL will be determined.
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Study week 2 (2 weeks after study medication start)
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Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 3
Lasso di tempo: Study week 3 (3 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 3 study visit.
The percentage of participants who have a serum corrected calcium <7.0 mg/dL will be determined.
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Study week 3 (3 weeks after study medication start)
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Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 4
Lasso di tempo: Study week 4 (4 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 4 study visit.
The percentage of participants who have a serum corrected calcium <7.0 mg/dL will be determined.
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Study week 4 (4 weeks after study medication start)
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Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 5
Lasso di tempo: Study week 5 (5 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 5 study visit.
The percentage of participants who have a serum corrected calcium <7.0 mg/dL will be determined.
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Study week 5 (5 weeks after study medication start)
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Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 6
Lasso di tempo: Study week 6 (6 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 6 study visit.
The percentage of participants who have a serum corrected calcium <7.0 mg/dL will be determined.
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Study week 6 (6 weeks after study medication start)
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Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 9
Lasso di tempo: Study week 9 (9 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 9 study visit.
The percentage of participants who have a serum corrected calcium <7.0 mg/dL will be determined.
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Study week 9 (9 weeks after study medication start)
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Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 13
Lasso di tempo: Study week 13 (13 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 13 study visit.
The percentage of participants who have a serum corrected calcium <7.0 mg/dL will be determined.
|
Study week 13 (13 weeks after study medication start)
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Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 17
Lasso di tempo: Study week 17 (17 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 17 study visit.
The percentage of participants who have a serum corrected calcium <7.0 mg/dL will be determined.
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Study week 17 (17 weeks after study medication start)
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Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 1.
Lasso di tempo: Study week 1 (1 week after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 1 study visit.
The percentage of participants who have a serum furosemide level >12 micrograms/L will be determined.
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Study week 1 (1 week after study medication start)
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Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 2.
Lasso di tempo: Study week 2 (2 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 2 study visit.
The percentage of participants who have a serum furosemide level >12 micrograms/L will be determined.
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Study week 2 (2 weeks after study medication start)
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Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 3.
Lasso di tempo: Study week 3 (3 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 3 study visit.
The percentage of participants who have a serum furosemide level >12 micrograms/L will be determined.
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Study week 3 (3 weeks after study medication start)
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Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 4.
Lasso di tempo: Study week 4 (4 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 4 study visit.
The percentage of participants who have a serum furosemide level >12 micrograms/L will be determined.
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Study week 4 (4 weeks after study medication start)
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Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 5.
Lasso di tempo: Study week 5 (5 weeks after study medication start)
|
Blood samples will be collected from participants prior to their dialysis treatments at the week 5 study visit.
The percentage of participants who have a serum furosemide level >12 micrograms/L will be determined.
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Study week 5 (5 weeks after study medication start)
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Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 6.
Lasso di tempo: Study week 6 (6 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 6 study visit.
The percentage of participants who have a serum furosemide level >12 micrograms/L will be determined.
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Study week 6 (6 weeks after study medication start)
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Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 9.
Lasso di tempo: Study week 9 (9 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 9 study visit.
The percentage of participants who have a serum furosemide level >12 micrograms/L will be determined.
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Study week 9 (9 weeks after study medication start)
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Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 13.
Lasso di tempo: Study week 13 (13 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 13 study visit.
The percentage of participants who have a serum furosemide level >12 micrograms/L will be determined.
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Study week 13 (13 weeks after study medication start)
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Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 17.
Lasso di tempo: Study week 17 (17 weeks after study medication start)
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Blood samples will be collected from participants prior to their dialysis treatments at the week 17 study visit.
The percentage of participants who have a serum furosemide level >12 micrograms/L will be determined.
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Study week 17 (17 weeks after study medication start)
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Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 1
Lasso di tempo: Up to study week 1 (1 week after study medication start)
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Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols.
Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g.
aortic dissection).
The percentage of participants who have dialysis-associated hypotension up to week 1 will be determined.
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Up to study week 1 (1 week after study medication start)
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Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 2
Lasso di tempo: Up to study week 2 (2 weeks after study medication start)
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Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols.
Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g.
aortic dissection).
The percentage of participants who have dialysis-associated hypotension up to week 2 will be determined.
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Up to study week 2 (2 weeks after study medication start)
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Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 3
Lasso di tempo: Up to study week 3 (3 weeks after study medication start)
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Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols.
Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g.
aortic dissection).
The percentage of participants who have dialysis-associated hypotension up to week 3 will be determined.
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Up to study week 3 (3 weeks after study medication start)
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Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 4
Lasso di tempo: Up to study week 4 (4 weeks after study medication start)
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Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols.
Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g.
aortic dissection).
The percentage of participants who have dialysis-associated hypotension up to week 4 will be determined.
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Up to study week 4 (4 weeks after study medication start)
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Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 5
Lasso di tempo: Up to study week 5 (5 weeks after study medication start)
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Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols.
Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g.
aortic dissection).
The percentage of participants who have dialysis-associated hypotension up to week 5 will be determined.
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Up to study week 5 (5 weeks after study medication start)
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Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 6
Lasso di tempo: Up to study week 6 (6 weeks after study medication start)
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Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols.
Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g.
aortic dissection).
The percentage of participants who have dialysis-associated hypotension up to week 6 will be determined.
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Up to study week 6 (6 weeks after study medication start)
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Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 7
Lasso di tempo: Up to study week 7 (7 weeks after study medication start)
|
Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols.
Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g.
aortic dissection).
The percentage of participants who have dialysis-associated hypotension up to week 7 will be determined.
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Up to study week 7 (7 weeks after study medication start)
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Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 8
Lasso di tempo: Up to study week 8 (8 weeks after study medication start)
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Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols.
Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g.
aortic dissection).
The percentage of participants who have dialysis-associated hypotension up to week 8 will be determined.
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Up to study week 8 (8 weeks after study medication start)
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Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 9
Lasso di tempo: Up to study week 9 (9 weeks after study medication start)
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Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols.
Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g.
aortic dissection).
The percentage of participants who have dialysis-associated hypotension up to week 9 will be determined.
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Up to study week 9 (9 weeks after study medication start)
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Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 10
Lasso di tempo: Up to study week 10 (10 weeks after study medication start)
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Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols.
Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g.
aortic dissection).
The percentage of participants who have dialysis-associated hypotension up to week 10 will be determined.
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Up to study week 10 (10 weeks after study medication start)
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Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 11
Lasso di tempo: Up to study week 11 (11 weeks after study medication start)
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Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols.
Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g.
aortic dissection).
The percentage of participants who have dialysis-associated hypotension up to week 11 will be determined.
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Up to study week 11 (11 weeks after study medication start)
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Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 12
Lasso di tempo: Up to study week 12 (12 weeks after study medication start)
|
Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols.
Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g.
aortic dissection).
The percentage of participants who have dialysis-associated hypotension up to week 12 will be determined.
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Up to study week 12 (12 weeks after study medication start)
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Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 13
Lasso di tempo: Up to study week 13 (13 weeks after study medication start)
|
Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols.
Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g.
aortic dissection).
The percentage of participants who have dialysis-associated hypotension up to week 13 will be determined.
|
Up to study week 13 (13 weeks after study medication start)
|
Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 14
Lasso di tempo: Up to study week 14 (14 weeks after study medication start)
|
Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols.
Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g.
aortic dissection).
The percentage of participants who have dialysis-associated hypotension up to week 14 will be determined.
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Up to study week 14 (14 weeks after study medication start)
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Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 15
Lasso di tempo: Up to study week 15 (15 weeks after study medication start)
|
Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols.
Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g.
aortic dissection).
The percentage of participants who have dialysis-associated hypotension up to week 15 will be determined.
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Up to study week 15 (15 weeks after study medication start)
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Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 16
Lasso di tempo: Up to study week 16 (16 weeks after study medication start)
|
Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols.
Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g.
aortic dissection).
The percentage of participants who have dialysis-associated hypotension up to week 16 will be determined.
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Up to study week 16 (16 weeks after study medication start)
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Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 17
Lasso di tempo: Up to study week 17 (17 weeks after study medication start)
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Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols.
Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g.
aortic dissection).
The percentage of participants who have dialysis-associated hypotension up to week 17 will be determined.
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Up to study week 17 (17 weeks after study medication start)
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Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 18
Lasso di tempo: Up to study week 18 (18 weeks after study medication start)
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Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols.
Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g.
aortic dissection).
The percentage of participants who have dialysis-associated hypotension up to week 18 will be determined.
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Up to study week 18 (18 weeks after study medication start)
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Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 1
Lasso di tempo: Study week 1 (1 week after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.
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Study week 1 (1 week after study medication start)
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Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 2
Lasso di tempo: Study week 2 (2 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.
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Study week 2 (2 weeks after study medication start)
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Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 3
Lasso di tempo: Study week 3 (3 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.
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Study week 3 (3 weeks after study medication start)
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Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 4
Lasso di tempo: Study week 4 (4 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.
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Study week 4 (4 weeks after study medication start)
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Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 5
Lasso di tempo: Study week 5 (5 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.
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Study week 5 (5 weeks after study medication start)
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Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 6
Lasso di tempo: Study week 6 (6 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.
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Study week 6 (6 weeks after study medication start)
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Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 8
Lasso di tempo: Study week 8 (8 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.
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Study week 8 (8 weeks after study medication start)
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Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 10
Lasso di tempo: Study week 10 (10 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.
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Study week 10 (10 weeks after study medication start)
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Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 12
Lasso di tempo: Study week 12 (12 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.
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Study week 12 (12 weeks after study medication start)
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Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 14
Lasso di tempo: Study week 14 (14 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.
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Study week 14 (14 weeks after study medication start)
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Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 16
Lasso di tempo: Study week 16 (16 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.
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Study week 16 (16 weeks after study medication start)
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Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 18
Lasso di tempo: Study week 18 (18 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.
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Study week 18 (18 weeks after study medication start)
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Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 1
Lasso di tempo: Study week 1 (1 week after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide.
Incidence will be defined as percentage of participants who have serious tinnitus.
The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.
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Study week 1 (1 week after study medication start)
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Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 2
Lasso di tempo: Study week 2 (2 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide.
Incidence will be defined as percentage of participants who have serious tinnitus.
The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.
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Study week 2 (2 weeks after study medication start)
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Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 3
Lasso di tempo: Study week 3 (3 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide.
Incidence will be defined as percentage of participants who have serious tinnitus.
The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.
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Study week 3 (3 weeks after study medication start)
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Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 4
Lasso di tempo: Study week 4 (4 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide.
Incidence will be defined as percentage of participants who have serious tinnitus.
The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.
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Study week 4 (4 weeks after study medication start)
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Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 5
Lasso di tempo: Study week 5 (5 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide.
Incidence will be defined as percentage of participants who have serious tinnitus.
The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.
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Study week 5 (5 weeks after study medication start)
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Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 6
Lasso di tempo: Study week 6 (6 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide.
Incidence will be defined as percentage of participants who have serious tinnitus.
The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.
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Study week 6 (6 weeks after study medication start)
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Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 8
Lasso di tempo: Study week 8 (8 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide.
Incidence will be defined as percentage of participants who have serious tinnitus.
The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.
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Study week 8 (8 weeks after study medication start)
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Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 10
Lasso di tempo: Study week 10 (10 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide.
Incidence will be defined as percentage of participants who have serious tinnitus.
The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.
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Study week 10 (10 weeks after study medication start)
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Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 12
Lasso di tempo: Study week 12 (12 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide.
Incidence will be defined as percentage of participants who have serious tinnitus.
The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.
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Study week 12 (12 weeks after study medication start)
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Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 14
Lasso di tempo: Study week 14 (14 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide.
Incidence will be defined as percentage of participants who have serious tinnitus.
The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.
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Study week 14 (14 weeks after study medication start)
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Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 16
Lasso di tempo: Study week 16 (16 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide.
Incidence will be defined as percentage of participants who have serious tinnitus.
The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.
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Study week 16 (16 weeks after study medication start)
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Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 18
Lasso di tempo: Study week 18 (18 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide.
Incidence will be defined as percentage of participants who have serious tinnitus.
The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.
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Study week 18 (18 weeks after study medication start)
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Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 1
Lasso di tempo: Study week 1 (1 week after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.
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Study week 1 (1 week after study medication start)
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Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 2
Lasso di tempo: Study week 2 (2 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.
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Study week 2 (2 weeks after study medication start)
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Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 3
Lasso di tempo: Study week 3 (3 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.
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Study week 3 (3 weeks after study medication start)
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Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 4
Lasso di tempo: Study week 4 (4 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.
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Study week 4 (4 weeks after study medication start)
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Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 5
Lasso di tempo: Study week 5 (5 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.
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Study week 5 (5 weeks after study medication start)
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Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 6
Lasso di tempo: Study week 6 (6 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.
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Study week 6 (6 weeks after study medication start)
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Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 8
Lasso di tempo: Study week 8 (8 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.
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Study week 8 (8 weeks after study medication start)
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Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 10
Lasso di tempo: Study week 10 (10 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.
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Study week 10 (10 weeks after study medication start)
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Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 12
Lasso di tempo: Study week 12 (12 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.
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Study week 12 (12 weeks after study medication start)
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Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 14
Lasso di tempo: Study week 14 (14 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.
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Study week 14 (14 weeks after study medication start)
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Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 16
Lasso di tempo: Study week 16 (16 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.
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Study week 16 (16 weeks after study medication start)
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Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 18
Lasso di tempo: Study week 18 (18 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.
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Study week 18 (18 weeks after study medication start)
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Change in the Inner EAR Instrument Score From Baseline to Week 1
Lasso di tempo: Baseline and study week 1 (1 week after study medication start)
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Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 1.
The total instrument score will be tallied at each administration [range: 10 (low hearing ability) - 59 (high hearing ability)].
Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score.
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Baseline and study week 1 (1 week after study medication start)
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Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 2
Lasso di tempo: Baseline and study week 2 (2 weeks after study medication start)
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Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 2. The total instrument score will be tallied at each administration [range: 10 (low hearing ability) - 59 (high hearing ability)].
Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score.
The percentage of participants with a defined decrease in the Inner EAR instrument score will be determined.
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Baseline and study week 2 (2 weeks after study medication start)
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Change in the Inner EAR Instrument Score From Baseline to Week 3
Lasso di tempo: Baseline and study week 3 (3 weeks after study medication start)
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Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 3.
The total instrument score will be tallied at each administration [range: 10 (low hearing ability) - 59 (high hearing ability)].
Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score.
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Baseline and study week 3 (3 weeks after study medication start)
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Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 4
Lasso di tempo: Baseline and study week 4 (4 weeks after study medication start)
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Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 4.
The total instrument score will be tallied at each administration [range: 10 (low hearing ability) - 59 (high hearing ability)].
Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score.
The percentage of participants with a defined decrease in the Inner EAR instrument score will be determined.
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Baseline and study week 4 (4 weeks after study medication start)
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Change in the Inner EAR Instrument Score From Baseline to Week 5
Lasso di tempo: Baseline and study week 5 (5 weeks after study medication start)
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Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 5.
The total instrument score will be tallied at each administration [range: 10 (low hearing ability) - 59 (high hearing ability)].
Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score.
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Baseline and study week 5 (5 weeks after study medication start)
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Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 6
Lasso di tempo: Baseline and study week 6 (6 weeks after study medication start)
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Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 6.
The total instrument score will be tallied at each administration [range: 10 (low hearing ability) - 59 (high hearing ability)].
Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score.
The percentage of participants with a defined decrease in the Inner EAR instrument score will be determined.
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Baseline and study week 6 (6 weeks after study medication start)
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Change in the Inner EAR Instrument Score From Baseline to Week 8
Lasso di tempo: Baseline and study week 8 (8 weeks after study medication start)
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Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 8.
The total instrument score will be tallied at each administration [range: 10 (low hearing ability) - 59 (high hearing ability)].
Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score.
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Baseline and study week 8 (8 weeks after study medication start)
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Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 10
Lasso di tempo: Baseline and study week 10 (10 weeks after study medication start)
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Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 10.
The total instrument score will be tallied at each administration [range: 10 (low hearing ability) - 59 (high hearing ability)].
Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score.
The percentage of participants with a defined decrease in the Inner EAR instrument score will be determined.
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Baseline and study week 10 (10 weeks after study medication start)
|
Change in the Inner EAR Instrument Score From Baseline to Week 12
Lasso di tempo: Baseline and study week 12 (12 weeks after study medication start)
|
Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 12.
The total instrument score will be tallied at each administration [range: 10 (low hearing ability) - 59 (high hearing ability)].
Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score.
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Baseline and study week 12 (12 weeks after study medication start)
|
Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 14
Lasso di tempo: Baseline and study week 14 (14 weeks after study medication start)
|
Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 14.
The total instrument score will be tallied at each administration [range: 10 (low hearing ability) - 59 (high hearing ability)].
Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score.
The percentage of participants with a defined decrease in the Inner EAR instrument score will be determined.
|
Baseline and study week 14 (14 weeks after study medication start)
|
Change in the Inner EAR Instrument Score From Baseline to Week 16
Lasso di tempo: Baseline and study week 16 (16 weeks after study medication start)
|
Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 16.
The total instrument score will be tallied at each administration [range: 10 (low hearing ability) - 59 (high hearing ability)].
Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score.
|
Baseline and study week 16 (16 weeks after study medication start)
|
Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 18
Lasso di tempo: Baseline and study week 18 (18 weeks after study medication start)
|
Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 18.
The total instrument score will be tallied at each administration [range: 10 (low hearing ability) - 59 (high hearing ability)].
Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score.
The percentage of participants with a defined decrease in the Inner EAR instrument score will be determined.
|
Baseline and study week 18 (18 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 1
Lasso di tempo: Study week 1 (1 week after study medication start)
|
Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.
|
Study week 1 (1 week after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 2
Lasso di tempo: Study week 2 (2 weeks after study medication start)
|
Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.
|
Study week 2 (2 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 3
Lasso di tempo: Study week 3 (3 weeks after study medication start)
|
Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.
|
Study week 3 (3 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 4
Lasso di tempo: Study week 4 (4 weeks after study medication start)
|
Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.
|
Study week 4 (4 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 5
Lasso di tempo: Study week 5 (5 weeks after study medication start)
|
Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.
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Study week 5 (5 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 6
Lasso di tempo: Study week 6 (6 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.
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Study week 6 (6 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 8
Lasso di tempo: Study week 8 (8 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.
|
Study week 8 (8 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 10
Lasso di tempo: Study week 10 (10 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.
|
Study week 10 (10 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 12
Lasso di tempo: Study week 12 (12 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.
|
Study week 12 (12 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 14
Lasso di tempo: Study week 14 (14 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.
|
Study week 14 (14 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 16
Lasso di tempo: Study week 16 (16 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.
|
Study week 16 (16 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 18
Lasso di tempo: Study week 18 (18 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.
|
Study week 18 (18 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 1
Lasso di tempo: Study week 1 (1 week after study medication start)
|
Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.
|
Study week 1 (1 week after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 2
Lasso di tempo: Study week 2 (2 weeks after study medication start)
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Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.
|
Study week 2 (2 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 3
Lasso di tempo: Study week 3 (3 weeks after study medication start)
|
Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.
|
Study week 3 (3 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 4
Lasso di tempo: Study week 4 (4 weeks after study medication start)
|
Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.
|
Study week 4 (4 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 5
Lasso di tempo: Study week 5 (5 weeks after study medication start)
|
Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.
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Study week 5 (5 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 6
Lasso di tempo: Study week 6 (6 weeks after study medication start)
|
Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.
|
Study week 6 (6 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 8
Lasso di tempo: Study week 8 (8 weeks after study medication start)
|
Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.
|
Study week 8 (8 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 10
Lasso di tempo: Study week 10 (10 weeks after study medication start)
|
Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.
|
Study week 10 (10 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 12
Lasso di tempo: Study week 12 (12 weeks after study medication start)
|
Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.
|
Study week 12 (12 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 14
Lasso di tempo: Study week 14 (14 weeks after study medication start)
|
Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.
|
Study week 14 (14 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 16
Lasso di tempo: Study week 16 (16 weeks after study medication start)
|
Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.
|
Study week 16 (16 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 18
Lasso di tempo: Study week 18 (18 weeks after study medication start)
|
Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.
|
Study week 18 (18 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 1
Lasso di tempo: Study week 1 (1 week after study medication start)
|
Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.
|
Study week 1 (1 week after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 2
Lasso di tempo: Study week 2 (2 weeks after study medication start)
|
Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.
|
Study week 2 (2 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 3
Lasso di tempo: Study week 3 (3 weeks after study medication start)
|
Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.
|
Study week 3 (3 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 4
Lasso di tempo: Study week 4 (4 weeks after study medication start)
|
Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.
|
Study week 4 (4 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 5
Lasso di tempo: Study week 5 (5 weeks after study medication start)
|
Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.
|
Study week 5 (5 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 6
Lasso di tempo: Study week 6 (6 weeks after study medication start)
|
Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.
|
Study week 6 (6 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 8
Lasso di tempo: Study week 8 (8 weeks after study medication start)
|
Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.
|
Study week 8 (8 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 10
Lasso di tempo: Study week 10 (10 weeks after study medication start)
|
Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.
|
Study week 10 (10 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 12
Lasso di tempo: Study week 12 (12 weeks after study medication start)
|
Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.
|
Study week 12 (12 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 14
Lasso di tempo: Study week 14 (14 weeks after study medication start)
|
Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.
|
Study week 14 (14 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 16
Lasso di tempo: Study week 16 (16 weeks after study medication start)
|
Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.
|
Study week 16 (16 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 18
Lasso di tempo: Study week 18 (18 weeks after study medication start)
|
Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.
|
Study week 18 (18 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 1
Lasso di tempo: Study week 1 (1 week after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe chest pain will be determined.
|
Study week 1 (1 week after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 2
Lasso di tempo: Study week 2 (2 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe chest pain will be determined.
|
Study week 2 (2 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 3
Lasso di tempo: Study week 3 (3 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe chest pain will be determined.
|
Study week 3 (3 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 4
Lasso di tempo: Study week 4 (4 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe chest pain will be determined.
|
Study week 4 (4 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 5
Lasso di tempo: Study week 5 (5 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe chest pain will be determined.
|
Study week 5 (5 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 6
Lasso di tempo: Study week 6 (6 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe chest pain will be determined.
|
Study week 6 (6 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 8
Lasso di tempo: Study week 8 (8 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe chest pain will be determined.
|
Study week 8 (8 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 10
Lasso di tempo: Study week 10 (10 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe chest pain will be determined.
|
Study week 10 (10 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 12
Lasso di tempo: Study week 12 (12 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe chest pain will be determined.
|
Study week 12 (12 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 14
Lasso di tempo: Study week 14 (14 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe chest pain will be determined.
|
Study week 14 (14 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 16
Lasso di tempo: Study week 16 (16 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe chest pain will be determined.
|
Study week 16 (16 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 18
Lasso di tempo: Study week 18 (18 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe chest pain will be determined.
|
Study week 18 (18 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 1
Lasso di tempo: Study week 1 (1 week after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe nausea will be determined.
|
Study week 1 (1 week after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 2
Lasso di tempo: Study week 2 (2 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe nausea will be determined.
|
Study week 2 (2 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 3
Lasso di tempo: Study week 3 (3 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe nausea will be determined.
|
Study week 3 (3 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 4
Lasso di tempo: Study week 4 (4 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe nausea will be determined.
|
Study week 4 (4 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 5
Lasso di tempo: Study week 5 (5 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe nausea will be determined.
|
Study week 5 (5 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 6
Lasso di tempo: Study week 6 (6 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe nausea will be determined.
|
Study week 6 (6 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 8
Lasso di tempo: Study week 8 (8 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe nausea will be determined.
|
Study week 8 (8 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 10
Lasso di tempo: Study week 10 (10 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe nausea will be determined.
|
Study week 10 (10 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 12
Lasso di tempo: Study week 12 (12 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe nausea will be determined.
|
Study week 12 (12 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 14
Lasso di tempo: Study week 14 (14 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe nausea will be determined.
|
Study week 14 (14 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 16
Lasso di tempo: Study week 16 (16 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe nausea will be determined.
|
Study week 16 (16 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 18
Lasso di tempo: Study week 18 (18 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe nausea will be determined.
|
Study week 18 (18 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 1
Lasso di tempo: Study week 1 (1 week after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe vomiting will be determined.
|
Study week 1 (1 week after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 2
Lasso di tempo: Study week 2 (2 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe vomiting will be determined.
|
Study week 2 (2 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 3
Lasso di tempo: Study week 3 (3 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe vomiting will be determined.
|
Study week 3 (3 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 4
Lasso di tempo: Study week 4 (4 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe vomiting will be determined.
|
Study week 4 (4 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 5
Lasso di tempo: Study week 5 (5 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe vomiting will be determined.
|
Study week 5 (5 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 6
Lasso di tempo: Study week 6 (6 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe vomiting will be determined.
|
Study week 6 (6 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 8
Lasso di tempo: Study week 8 (8 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe vomiting will be determined.
|
Study week 8 (8 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 10
Lasso di tempo: Study week 10 (10 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe vomiting will be determined.
|
Study week 10 (10 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 12
Lasso di tempo: Study week 12 (12 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe vomiting will be determined.
|
Study week 12 (12 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 14
Lasso di tempo: Study week 14 (14 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe vomiting will be determined.
|
Study week 14 (14 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 16
Lasso di tempo: Study week 16 (16 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe vomiting will be determined.
|
Study week 16 (16 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 18
Lasso di tempo: Study week 18 (18 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe vomiting will be determined.
|
Study week 18 (18 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 1
Lasso di tempo: Study week 1 (1 week after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe diarrhea will be determined.
|
Study week 1 (1 week after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 2
Lasso di tempo: Study week 2 (2 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe diarrhea will be determined.
|
Study week 2 (2 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 3
Lasso di tempo: Study week 3 (3 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe diarrhea will be determined.
|
Study week 3 (3 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 4
Lasso di tempo: Study week 4 (4 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe diarrhea will be determined.
|
Study week 4 (4 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 5
Lasso di tempo: Study week 5 (5 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe diarrhea will be determined.
|
Study week 5 (5 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 6
Lasso di tempo: Study week 6 (6 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe diarrhea will be determined.
|
Study week 6 (6 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 8
Lasso di tempo: Study week 8 (8 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe diarrhea will be determined.
|
Study week 8 (8 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 10
Lasso di tempo: Study week 10 (10 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe diarrhea will be determined.
|
Study week 10 (10 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 12
Lasso di tempo: Study week 12 (12 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe diarrhea will be determined.
|
Study week 12 (12 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 14
Lasso di tempo: Study week 14 (14 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe diarrhea will be determined.
|
Study week 14 (14 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 16
Lasso di tempo: Study week 16 (16 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe diarrhea will be determined.
|
Study week 16 (16 weeks after study medication start)
|
Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 18
Lasso di tempo: Study week 18 (18 weeks after study medication start)
|
Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18.
Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe).
Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide.
The percentage of participants reporting severe or very severe diarrhea will be determined.
|
Study week 18 (18 weeks after study medication start)
|
Percentage of Participants Reporting Acceptance of Furosemide at Week 1
Lasso di tempo: Study week 1 (1 week after study medication start)
|
Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 1.
Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response ("yes") to the question "If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?".
The percentage of participants reporting acceptance of furosemide will be determined.
|
Study week 1 (1 week after study medication start)
|
Percentage of Participants Reporting Acceptance of Furosemide at Week 2
Lasso di tempo: Study week 2 (2 weeks after study medication start)
|
Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 2. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response ("yes") to the question "If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?".
The percentage of participants reporting acceptance of furosemide will be determined.
|
Study week 2 (2 weeks after study medication start)
|
Percentage of Participants Reporting Acceptance of Furosemide at Week 3
Lasso di tempo: Study week 3 (3 weeks after study medication start)
|
Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 3. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response ("yes") to the question "If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?".
The percentage of participants reporting acceptance of furosemide will be determined.
|
Study week 3 (3 weeks after study medication start)
|
Percentage of Participants Reporting Acceptance of Furosemide at Week 4
Lasso di tempo: Study week 4 (4 weeks after study medication start)
|
Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 4. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response ("yes") to the question "If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?".
The percentage of participants reporting acceptance of furosemide will be determined.
|
Study week 4 (4 weeks after study medication start)
|
Percentage of Participants Reporting Acceptance of Furosemide at Week 5
Lasso di tempo: Study week 5 (5 weeks after study medication start)
|
Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 5. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response ("yes") to the question "If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?".
The percentage of participants reporting acceptance of furosemide will be determined.
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Study week 5 (5 weeks after study medication start)
|
Percentage of Participants Reporting Acceptance of Furosemide at Week 6
Lasso di tempo: Study week 6 (6 weeks after study medication start)
|
Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 6.
Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response ("yes") to the question "If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?".
The percentage of participants reporting acceptance of furosemide will be determined.
|
Study week 6 (6 weeks after study medication start)
|
Percentage of Participants Reporting Acceptance of Furosemide at Week 8
Lasso di tempo: Study week 8 (8 weeks after study medication start)
|
Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 8. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response ("yes") to the question "If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?".
The percentage of participants reporting acceptance of furosemide will be determined.
|
Study week 8 (8 weeks after study medication start)
|
Percentage of Participants Reporting Acceptance of Furosemide at Week 10
Lasso di tempo: Study week 10 (10 weeks after study medication start)
|
Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 10.
Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response ("yes") to the question "If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?".
The percentage of participants reporting acceptance of furosemide will be determined.
|
Study week 10 (10 weeks after study medication start)
|
Percentage of Participants Reporting Acceptance of Furosemide at Week 12
Lasso di tempo: Study week 12 (12 weeks after study medication start)
|
Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 12. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response ("yes") to the question "If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?".
The percentage of participants reporting acceptance of furosemide will be determined.
|
Study week 12 (12 weeks after study medication start)
|
Percentage of Participants Reporting Acceptance of Furosemide at Week 14
Lasso di tempo: Study week 14 (14 weeks after study medication start)
|
Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 14.
Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response ("yes") to the question "If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?".
The percentage of participants reporting acceptance of furosemide will be determined.
|
Study week 14 (14 weeks after study medication start)
|
Percentage of Participants Reporting Acceptance of Furosemide at Week 16
Lasso di tempo: Study week 16 (16 weeks after study medication start)
|
Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 16.
Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response ("yes") to the question "If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?".
The percentage of participants reporting acceptance of furosemide will be determined.
|
Study week 16 (16 weeks after study medication start)
|
Percentage of Participants Reporting Acceptance of Furosemide at Week 18
Lasso di tempo: Study week 18 (18 weeks after study medication start)
|
Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 18.
Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response ("yes") to the question "If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?".
The percentage of participants reporting acceptance of furosemide will be determined.
|
Study week 18 (18 weeks after study medication start)
|
Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 1
Lasso di tempo: Study week 1 (1 week after study medication start)
|
Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 1.
Participants' adherence to furosemide will be defined <20% pills remaining at the scheduled pill counts.
The percentage of participants who are adherent to furosemide will be determined.
|
Study week 1 (1 week after study medication start)
|
Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 2
Lasso di tempo: Study week 2 (2 weeks after study medication start)
|
Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 2. Participants' adherence to furosemide will be defined <20% pills remaining at the scheduled pill counts.
The percentage of participants who are adherent to furosemide will be determined.
|
Study week 2 (2 weeks after study medication start)
|
Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 3
Lasso di tempo: Study week 3 (3 weeks after study medication start)
|
Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 3. Participants' adherence to furosemide will be defined <20% pills remaining at the scheduled pill counts.
The percentage of participants who are adherent to furosemide will be determined.
|
Study week 3 (3 weeks after study medication start)
|
Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 4
Lasso di tempo: Study week 4 (4 weeks after study medication start)
|
Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 4. Participants' adherence to furosemide will be defined <20% pills remaining at the scheduled pill counts.
The percentage of participants who are adherent to furosemide will be determined.
|
Study week 4 (4 weeks after study medication start)
|
Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 5
Lasso di tempo: Study week 5 (5 weeks after study medication start)
|
Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 5. Participants' adherence to furosemide will be defined <20% pills remaining at the scheduled pill counts.
The percentage of participants who are adherent to furosemide will be determined.
|
Study week 5 (5 weeks after study medication start)
|
Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 6
Lasso di tempo: Study week 6 (6 weeks after study medication start)
|
Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 6.
Participants' adherence to furosemide will be defined <20% pills remaining at the scheduled pill counts.
The percentage of participants who are adherent to furosemide will be determined.
|
Study week 6 (6 weeks after study medication start)
|
Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 8
Lasso di tempo: Study week 8 (8 weeks after study medication start)
|
Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 8. Participants' adherence to furosemide will be defined <20% pills remaining at the scheduled pill counts.
The percentage of participants who are adherent to furosemide will be determined.
|
Study week 8 (8 weeks after study medication start)
|
Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 10
Lasso di tempo: Study week 10 (10 weeks after study medication start)
|
Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 10.
Participants' adherence to furosemide will be defined <20% pills remaining at the scheduled pill counts.
The percentage of participants who are adherent to furosemide will be determined.
|
Study week 10 (10 weeks after study medication start)
|
Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 12
Lasso di tempo: Study week 12 (12 weeks after study medication start)
|
Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 12. Participants' adherence to furosemide will be defined <20% pills remaining at the scheduled pill counts.
The percentage of participants who are adherent to furosemide will be determined.
|
Study week 12 (12 weeks after study medication start)
|
Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 14
Lasso di tempo: Study week 14 (14 weeks after study medication start)
|
Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 14.
Participants' adherence to furosemide will be defined <20% pills remaining at the scheduled pill counts.
The percentage of participants who are adherent to furosemide will be determined.
|
Study week 14 (14 weeks after study medication start)
|
Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 16
Lasso di tempo: Study week 16 (16 weeks after study medication start)
|
Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 16.
Participants' adherence to furosemide will be defined <20% pills remaining at the scheduled pill counts.
The percentage of participants who are adherent to furosemide will be determined.
|
Study week 16 (16 weeks after study medication start)
|
Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 18
Lasso di tempo: Study week 18 (18 weeks after study medication start)
|
Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 18.
Participants' adherence to furosemide will be defined <20% pills remaining at the scheduled pill counts.
The percentage of participants who are adherent to furosemide will be determined.
|
Study week 18 (18 weeks after study medication start)
|
Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 19
Lasso di tempo: Study week 19 (19 weeks after study medication start)
|
Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 19.
Participants' adherence to furosemide will be defined <20% pills remaining at the scheduled pill counts.
The percentage of participants who are adherent to furosemide will be determined.
|
Study week 19 (19 weeks after study medication start)
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Jennifer Flythe, MD, MPH, University of North Carolina, Chapel Hill
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 19-3550
- 1R03DK124651-01 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- Protocollo di studio
- Piano di analisi statistica (SAP)
- Modulo di consenso informato (ICF)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
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