A Study of Darolutamide Plus Androgen Deprivation Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer in India (PACE mHSPC)
An Active Post Marketing Surveillance (PMS) Observational Study of Darolutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Typ studie
Typ studie
Zápis (Odhadovaný)
Zápis
Kontakty a umístění
Studijní kontakt
Studijní kontakt
- Jméno: Bayer Clinical Trials Contact
- Telefonní číslo: 4930300139003
- E-mail: clinical-trials-contact@bayer.com
Studijní místa
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Many Locations, Indie
- Many locations
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Men over the age of 18 years
- Histologically or cytologically confirmed adenocarcinoma of prostate
- Metastatic disease (metastatic hormone sensitive prostate cancer) documented by either by a positive bone scan, or for soft tissue either by contrast-enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan assessed by investigators
- The decision to initiate treatment with darolutamide plus androgen deprivation therapy (ADT) was made as per the investigator's routine treatment practice
- Written informed consent
Exclusion Criteria:
- Participation in an interventional clinical trial program with interventions outside of routine clinical practice
- Any condition that, in investigator's opinion, precludes reliable safety follow-up.
- Concomitant use or planned to start the use of docetaxel/any other androgen receptor inhibitors/radiation therapy/chemotherapy or immunotherapy
- Known hypersensitivity to the study drug or any of its ingredients
- Metastatic castration resistant prostate cancer (mCRPC) disease
Studijní plán
Jak je studie koncipována?
Detaily designu
Počet skupin / kohort
Kohorty a intervence
Skupina / kohortaSkupina / kohorta |
Intervence / LéčbaIntervence / Léčba |
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Single-arm post marketing surveillance cohort
Patients with metastatic hormone-sensitive prostate cancer in India who are treated with darolutamide in combination with androgen deprivation therapy as part of routine clinical practice
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Darolutamide 300 mg film-coated tablets in combination with androgen deprivation therapy (ADT).
The decision on the dose and duration of treatment is solely at the discretion of the treating physician, based on the recommendations written in the local product information.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Incidence and severity of adverse events and serious adverse events
Časové okno: From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months
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Occurrence of adverse events, including AE/SAE terms, dates, severity as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, causality, outcome, actions taken, and seriousness criteria
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From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months
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Incidence of discontinuations and dose modifications of study drug due to adverse events
Časové okno: From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months
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Adverse event-related drug discontinuations/modifications, including adverse events leading to dose modification/discontinuation, dates, and reason
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From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months
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Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Changes in hematology laboratory parameters: hemoglobin
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: hematocrit
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: erythrocyte count
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: leukocyte count
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: lymphocytes
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: monocytes
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: eosinophils
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: neutrophils
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: basophils
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: mean corpuscular hemoglobin
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: mean corpuscular volume
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: mean corpuscular hemoglobin concentration
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: thrombocytes
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: albumin
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: alanine aminotransferase
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: aspartate aminotransferase
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: alkaline phosphatase
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: gamma-glutamyl transferase
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: bilirubin total and direct
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: calcium
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: blood urea nitrogen
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: creatinine
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: serum glucose
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: total protein
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: lactate dehydrogenase
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: sodium
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: potassium
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: chloride
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: bicarbonate
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: testosterone
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: total prostate-specific antigen (PSA)
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: prothrombin time
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: international normalized ratio (INR)
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in routine urinalysis parameters: specific gravity
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in routine urinalysis parameters: pH, by dipstick
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in routine urinalysis parameters: glucose, by dipstick
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in routine urinalysis parameters: protein, by dipstick
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in routine urinalysis parameters: blood, by dipstick
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in routine urinalysis parameters: ketones, by dipstick
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in routine urinalysis parameters: microscopic examination
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Microscopic examination, if blood or protein urinalysis by dipstick is abnormal
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Results of other safety laboratory tests
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Results of other safety laboratory tests performed as deemed necessary by the investigator
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in Eastern Cooperative Oncology Group performance status and vitals
Časové okno: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Eastern Cooperative Oncology Group performance status on a scale from 0 to 5
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Incidence and severity of adverse events categorized as special topics
Časové okno: From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months
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Occurrence of adverse events categorized as special topics, including category, severity as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, causality, actions taken, hospitalization, and discontinuation. Special topics are defined as:
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From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months
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Drug administration status
Časové okno: From baseline/first dose through the treatment and observation period, over a total duration of approximately 12 months
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Drug exposure and modifications, including start/stop dates, dose, interruptions, reductions, discontinuation reasons, and cumulative dose
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From baseline/first dose through the treatment and observation period, over a total duration of approximately 12 months
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Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Začátek studia
Primární dokončení (Odhadovaný)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- 23276
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