B-CD30 + Hodgkin Lymphoma International Multi-center Retrospective Study of Treatment Practices and Outcomes (B-HOLISTIC)
3. června 2021 aktualizováno: Takeda
An International, Multi-centre, Non-interventional Retrospective Study to Describe Treatment Pathways, Outcomes, and Resource Use in Patients With Classical Hodgkin Lymphoma (B-HOLISTIC)
The purpose of this study is to describe progression-free survival (PFS) in participants with relapsed or refractory classical Hodgkin lymphoma (RRHL), defined as the time from initiation of first treatment for RRHL to first documentation of relapse or disease progression, or death.
Přehled studie
Postavení
Dokončeno
Detailní popis
This is a retrospective, non-interventional study of participants with newly-diagnosed cHL, or with RRHL. The study will review the medical records of participants to describe participant's demographics, disease characteristics, treatments received, outcomes, health resources used by the participants, and adverse events that are associated with treatments, and resources used for treatment.
The study will enroll approximately 50 to 100 participants in each group at each of the 13 participating countries. Based on the diagnosis of the disease, participants will be assigned to one of the following groups:
Group 1: cHL Group 2: RRHL
This multi-center trial will be conducted in Argentina, Australia, China, Colombia, Hong Kong, Mexico, Republic of Korea, Russia, Saudi Arabia, Singapore, South Africa, Taiwan, and Turkey. The data for Group 1 and Group 2 will be collected from date of cHL or RRHL diagnosis until the date of death (or the date when the participant was last known to be alive, whichever occurs first).
Typ studie
Pozorovací
Zápis (Aktuální)
1770
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Busan, Korejská republika, 49241
- Pusan National University Hospital
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
Participants diagnosed with high-risk stage IIb-IV cHL and/or with RRHL between 01 January 2010 and 31st December 2013 from the 13 participating countries.
Popis
Inclusion Criteria:
- Participants newly diagnosed with high-risk stage IIb-IV cHL (for Group 1) or RRHL (for Group 2) between 01 January 2010 and 31 December 2013.
- Age greater than or equal to (>=) 18 years at diagnosis of cHL (Group 1) or RRHL (Group 2).
- Alive or deceased.
- Written informed consent is obtained for study data collection, where necessary, according to local regulations.
Exclusion Criteria:
- Participants for whom the minimum study dataset is not available from their hospital medical records.
- Participants who have participated in an interventional clinical trial at any stage of their cHL (Group 1) or RRHL (Group 2) management.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Observační modely: Kohorta
- Časové perspektivy: Retrospektivní
Kohorty a intervence
Skupina / kohorta |
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Group 1: cHL
Participants diagnosed with high-risk stage IIb-IV cHL, received frontline treatment with chemotherapy with or without radiotherapy between 01 January 2010 and 31 December 2013 from the 13 participating countries will be observed for various treatments received for cHL, associated adverse events and resources used from the date of cHL diagnosis until the date of first documented relapse or disease progression after frontline therapy.
Participants will be continue to be observed for overall survival until the date of death or data collection, whichever occurs first.
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Group 2: RRHL
Participants diagnosed with RRHL, between 01 January 2010 and 31 December 2013 from the 13 participating countries will be observed for various treatments received for RRHL, detailed data on treatment pathways, clinical outcomes, associated adverse events and resources used from the date of RRHL diagnosis until the date death or data collection, whichever occurs first.
Participants will be continue to be observed for overall survival until the date of death or data collection, whichever occurs first.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Group 2, RRHL: Progression Free Survival (PFS)
Časové okno: From initiation of first treatment until first documentation of relapse/PD/until date of death (or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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PFS was defined as time from initiation of frontline regimen to first documentation of relapse or disease progression or death, censored at date of most recent follow-up/contact.
Progressive disease (PD) was defined as any new lesion or increase by >=50% of previously involved site from nadir, and was evaluated based on International Working Group (IWG) criteria (Cheson et al 2007).
Median PFS was estimated using the Kaplan-Meier method.
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From initiation of first treatment until first documentation of relapse/PD/until date of death (or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Group 1, cHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis
Časové okno: Day 1 at cHL diagnosis
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The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread.
Stages are classified by Roman numerals I (lessspread) to IV (more spread).
Additional sub staging variables include: A, asymptomatic; and B, presence of B symptoms (including fever, night sweats and weight loss of >=10 percent [%] of body weight over 6 months).
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Day 1 at cHL diagnosis
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Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis
Časové okno: Day 1 at RRHL diagnosis
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The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread.
Stages are classified by Roman numerals I (lessspread) to IV (more spread).
Additional sub staging variables include: A, asymptomatic; and B, presence of B symptoms (including fever, night sweats and weight loss of >=10 % of body weight over 6 months).
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Day 1 at RRHL diagnosis
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Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis
Časové okno: At second, third, fourth, and fifth relapse (up to 9 years 10 months)
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The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread.
Stages are classified by Roman numerals I (less spread) to IV (more spread).
Additional sub staging variables include: A, asymptomatic; and B, presence of B symptoms (including fever, night sweats and weight loss of >=10% of body weight over 6 months).
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At second, third, fourth, and fifth relapse (up to 9 years 10 months)
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Group 1, cHL: Number of Participants Based on Each International Prognostic Score (IPS) Category
Časové okno: Day 1 at cHL diagnosis
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IPS score was calculated based on following factors: age >=45 years, male sex, stage IV disease, albumin<4 gram per liter (g/L), white blood cell (WBC)>=15*10^9 per liter (/L), haemoglobin <10.5 g/L, and lymphocyte count<0.6*10^6/L
or <8% of differential.
One point was assigned for each of above factors.
The sum of points allotted correlates with following risk groups: good risk (0-1 points)-5 year survival of 89-90%; fair risk (2 to 3 points)-5 year survival of 78-81%; poor risk (4-7 points)-5 year survival of 56-61%.
Total score range is 0 to 7, lower scores indicate higher survival rate.
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Day 1 at cHL diagnosis
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Group 1, cHL: Number of Participants With B Symptoms at Diagnosis
Časové okno: Day 1 at cHL diagnosis
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The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread.
Stages are classified by Roman numerals I (less spread) to IV (more spread).
If the following symptoms (B-symptoms) are present, a "B" classification is added to the stage: fever, night sweats and weight loss of >=10% of body weight over 6 months.
B-symptoms indicate the presence of systemic symptoms.
The presence or absence of B-symptoms has prognostic significance and is reflected in the staging of these lymphomas.
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Day 1 at cHL diagnosis
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Group 2, RRHL: Number of Participants With B Symptoms at Diagnosis
Časové okno: Day 1 at RRHL diagnosis
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The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread.
Stages are classified by Roman numerals I (less spread) to IV (more spread).
If the following symptoms (B-symptoms) are present, a "B" classification is added to the stage: fever, night sweats and weight loss of >=10% of body weight over 6 months.
B-symptoms indicate the presence of systemic symptoms.
The presence or absence of B-symptoms has prognostic significance and is reflected in the staging of these lymphomas.
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Day 1 at RRHL diagnosis
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Group 2, RRHL: Number of Participants Categorized Based on Prior Therapies for Hodgkin Lymphoma (HL) at Each Line of Treatment
Časové okno: Day 1 at RRHL diagnosis
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Number of participants were categorized based on prior therapies for HL at each line of treatment.
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Day 1 at RRHL diagnosis
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Group 2, RRHL: Median Number of Previous Treatment Regimens (Chemotherapies) Received
Časové okno: Day 1 at RRHL diagnosis
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Day 1 at RRHL diagnosis
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Group 1, cHL: Number of Participants Categorized Based on Frontline Treatment Regimens
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Therapy regimens were numbered as 1: Doxorubicin (Doxo) + Bleomycin (bleo) + Vinblastine (Vinbl) + Decarbazine (Dacar) (ABVD); 3: Doxo + Vinbl + Mechlorethamine + Etoposide (Eto) + Vincristilne (Vinc) + Bleo + Prednisone (Pred) (Stanford V); 6: Cyclophophamide (Cyclo) + Vinc + Procarbazine (Procarb) + Pred (C-MOPP); 7: Dexamethasone + Cytarabine + Cisplatin (DHAP); 8: Eto + Methylprednisolone + Cytarabine + Cisplatin (ESHAP); 10: Ifosfamide+ Carboplatin + Eto (ICE); 11: Ifosfamide + Gemcitabine +Vinorelbine + Pred (IGEV); 17: Rituximab; 18: Brentuximab vedotin; 4: Bleo + Eto + Doxo + Cyclo + Vinc + Procarb + Pred (BEACOPP); 14: Cycl + Doxo + Vinc + Pred (CHOP); 15: Cycl + Vinc + Pred (CVP); 2: ABVD + Doxo + Bleo + Vinbl + Dacar then Bleo + Eto + Doxo + Cycl + Vinc + Procarb+ Pred ( Escalated BEACOPP); 24: Other.
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From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Group 1, cHL: Median Number of Treatment Cycles Associated With Each Frontline Treatment Regimen
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Therapy regimens were numbered as 1: ABVD; 3: Stanford V; 6: C-MOPP; 7: DHAP; 8: ESHAP; 10: ICE; 11: IGEV; 17: Rituximab; 18: Brentuximab vedotin; 4: BEACOPP; 14: CHOP; 15: CVP; 2: ABVD + Escalated BEACOPP; 24: Other.
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From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Group 1, cHL: Number of Participants Who Received Treatments for HL After Completion of Frontline Therapy (Before Relapse)
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Therapy regimens were numbered as 1: ABVD; 6: C-MOPP; 7: DHAP; 8: ESHAP; 10: ICE; 11: IGEV; 12: Carmustine + Cytarabine + Etoposide + Melphalan (Mini-BEAM); 13: Etoposide + Ifosfamide + Mesna + Mitoxantrone (MINE); 18: Brentuximab vedotin; 16: Gemcitabine + Vinoreilbine + Pegylated liposomal doxorubicin (GVD); 4: BEACOPP; 14: CHOP; 24: Other.
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From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Group 1, cHL: Number of Participants Categorized Based on RT Treatment Given as Pre-planned Frontline Treatment and RT Treatment Given for Residual Fluorodeoxyglucose (FDG)-Avid Disease
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Assessment was done for RT's whether used for pre-planned frontline treatment or for residual Fluorodeoxyglucose (FDG)-avid disease.
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From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Group 2, RRHL: Percentage of Participants Categorized Based on ASCT Eligibility Assessment
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Group 2, RRHL: Median Number of Treatment Cycles Associated With Relapse/ Refractory Treatment Regimen for ASCT
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Therapy regimens were numbered as 1: ABVD; 6: C-MOPP; 8: ESHAP; 11: IGEV; 12: Mini-BEAM; 18: Brentuximab vedotin; 22: Nivolumab; 24: Other.
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From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Reasons for Not Undergoing ASCT Despite Being ASCT Eligible
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Reasons for ASCT-eligible participants for not undergoing ASCT included participant refusal, inability to mobilize stem cells, loss of response to chemotherapy, cumulative toxicities, comorbid conditions, others, and unknown.
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From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Group 2, RRHL: Number of Non-ASCT Participants Based on Reasons for ASCT Ineligibility
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Reasons for ASCT ineligibility included advanced age, comorbid conditions, chemoresistant disease, cumulative toxicities, and others.
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From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Therapy regimens were numbered as 1: ABVD; 2: ABVD followed by Escalated BEACOPP; 3: Stanford V; 4: BEACOPP; 6: Cyclophosphamide C-MOPP; 7: DHAP; 8: ESHAP; 9: GCD; 10: ICE; 11: IGEV; 12: Mini-BEAM; 13: MINE; 14: CHOP; 15: CVP; 16: GVD; 17: Rituximab; 18: Brentuximab vedotin; 19: Bendamustine; 22: Nivolumab; 23: Pembrolizumab; 24: Other.
More than one line of treatment or therapy was selected for each participant.
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From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Group 2, RRHL: Percentage of Non-ASCT Participants for Whom Treatment is Palliative
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Group 2, RRHL: Percentage of Non-ASCT Participants Receiving Positron Emission Tomography (PET) or Computed Tomography (CT) at Each Line of Treatment Pathway
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Group 2, RRHL: Percentage of Non-ASCT Participants Receiving RT at Each Line of Treatment Pathway
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Group 2, RRHL: Median Frequency of PET or PET-CT Scan Assessment for Non-ASCT Participants
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants
Časové okno: From initiation of first treatment until first documentation of relapse/PD/until date of death( or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Therapy regimens were numbered as 1: ABVD; 3: Stanford V; 6: C-MOPP; 7: DHAP; 11: IGEV; 19: Bendamustine; 4: BEACOPP; 13: MINE; 14: CHOP; 24: Other; 8: ESHAP; 9: Gemcitabine + Carboplatin + Dexamethasone (GCD); 10: ICE; 17: Rituximab; 18: Brentuximab vedotin; 15: CVP; 2: ABVD followed by Escalated BEACOPP; 22: Nivolumab; 16: GVD; 21: Lenalidomide; 24: Other.
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From initiation of first treatment until first documentation of relapse/PD/until date of death( or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Group 2, RRHL: Duration of Each Line of Treatment in Non-ASCT Participants
Časové okno: From initiation of first treatment until first documentation of relapse/PD/until date of death( or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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From initiation of first treatment until first documentation of relapse/PD/until date of death( or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Therapy regimens were numbered as 1: ABVD; 3: Stanford V; 6: C-MOPP; 7: DHAP; 11: IGEV; 4: BEACOPP; 14: CHOP; 15: CVP; 2: ABVD followed by Escalated BEACOPP; 24: Other; 8: ESHAP; 9: GCD; 10: ICE; 13: MINE; 17: Rituximab; 18: Brentuximab vedotin; 19: Bendamustine; 22: Nivolumab.
More than one line of treatment or therapy was selected for each participant
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From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Group 2, RRHL: Time From Relapse (After Frontline Treatment) to First Treatment Post-relapse in Non-ASCT Participants
Časové okno: From relapse after frontline treatment to first treatment post-relapse or until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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From relapse after frontline treatment to first treatment post-relapse or until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Group 2, RRHL: Time to Initiation of Each Subsequent Treatment, From Relapse and Completion of Previous Treatment in Non-ASCT Participants
Časové okno: From both relapse and from completion of previous treatment to initiation of each subsequent treatment (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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From both relapse and from completion of previous treatment to initiation of each subsequent treatment (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site Received at Frontline
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site at Relapse/ Refractory
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Group 2, RRHL: Total Dose of Radiotherapies in Non-ASCT Participants
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Group 2, RRHL: Number of PET or CT Scan Assessments
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Group 2, RRHL: Number of Participants Categorized Based on Various Chemotherapeutic Regimen and Therapies Used in Participants Undergoing ASCT
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Therapy regimens were numbered as 8: ESHAP; 10: ICE; 11: IGEV; 12: Mini-BEAM; 18: Brentuximab vedotin; 19: Bendamustine; 16: GVD; 24: Other.
Conditioning regimens are BEAM (Carmustine + Etoposide + Cytarabine + Melphalan), CBV (cyclophosphamide + Carmustine + vp16) BeEAM (bendamustine) and Gemcitabine/Busulfan/Melphalan.
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From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Group 2, RRHL: Number of Participants Categorized Based on With Known Risk Factors for Relapse Post ASCT in Participants Undergoing ASCT
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Known risk factors for relapse after ASCT included time to first relapse less than or equal to (<=) 3 months, stage IV disease at relapse, bulky disease >=5 centimeter (cm) at relapse, extranodal disease, inadequate response to salvage chemotherapy (partial remission [PR] or PET positivity), performance status (eastern Cooperative oncology group [ECOG]) >=1.
The ECOG assessment used a 3-point scale, including scores of 0 (fully active/able to carry on all pre-disease activities without restriction), 1 (restricted in physically strenuous activity but ambulatory/able to carry out light or sedentary work), or 2 (ambulatory for more than 50% of waking hours and capable of all self care but unable to carry out any work activities).
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From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Group 2, RRHL: Median Number of Cycles Associated With Each Salvage Regimen in Participants Undergoing ASCT
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Therapy regimens were numbered as 1: ABVD; 6: C-MOPP; 7: DHAP; 8: ESHAP; 9: GCD; 10: ICE; 11: IGEV; 12: Mini-BEAM; 13: Eto + Ifosfamide + Mesna + Mitoxantrone (MINE); 18: Brentuximab vedotin; 19: Bendamustine; 22: Nivolumab; 16: GVD; 4: BEACOPP; 14: CHOP; 2: ABVD + Escalated BEACOPP; 24: Other.
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From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Group 2, RRHL: Percentage of Participants Receiving Consolidation Therapy Post-ASCT in Participants Undergoing ASCT
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Group 2, RRHL: Median Duration of Treatment for Consolidation Therapies Used in Participants Undergoing ASCT
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
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Group 2, RRHL: Number of Participants Categorized Based on Source of ASCT Procedures in Participants Undergoing ASCT
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
|
Group 2, RRHL: Median Time From Relapse (After End of Frontline Treatment) to ASCT in Participants Undergoing ASCT
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
|
Group 2, RRHL: CD34+ Count Administered in Participants Undergoing ASCT
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
|
Group 2, RRHL: Time From ASCT to First Relapse in Participants Who Relapse After ASCT
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
|
Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
Therapy regimens were numbered as 1: ABVD; 7: DHAP; 10: ICE; 11: IGEV; 4: BEACOPP; 2: ABVD followed by Escalated BEACOPP; 8: ESHAP; 12: Mini-BEAM; 13: MINE; 18: Brentuximab vedotin; 22: Nivolumab; 23: Pembrolizumab; 16: GVD, 9: GCD; 24: other; 19: Bendamustine; 14: CHOP; 17: Rituximab.
|
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
Group 2, RRHL: Percentage of Participants Who Relapse After ASCT Categorized Based on Palliative Therapy Regimens
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
Therapy regimens were numbered as 9: GVD; 10: ICE; 11: IGEV; 12: Mini-BEAM; 18: Brentuximab vedotin; 19: Bendamustine; 22: Nivolumab.
|
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
Therapy regimens were numbered as 1: ABVD; 7: DHAP; 10: ICE; 11: IGEV; 4: BEACOPP; 2: ABVD followed by Escalated BEACOPP; 8: ESHAP; 12: Mini-BEAM; 13: MINE; 18: Brentuximab vedotin; 9: GCD; 22: Nivolumab; 23: Pembrolizumab; 16: GVD.
|
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
Group 2, RRHL: Duration of Each Line of Treatment for Participants Who Relapse After ASCT
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
|
Group 2, RRHL: Time From ASCT to First Treatment After Relapse in Participants Who Relapse After ASCT
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
|
Group 2, RRHL: Time to Initiation of Each Subsequent Treatment, From ASCT and From Completion of Previous Treatment in Participants Who Relapse From ASCT
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
|
Group 2, RRHL: Percentage of Participants Who Received PET-CT Scan, CT Scan and Radiotherapy at Each Stage of the Treatment Pathway in Participants Who Relapse After ASCT
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
Data for PET-CT scan and CT scans were assessed for baseline, frontline and relapse/or refractory, and radiotherapy was assessed for frontline and relapse/refractory, as planned.
|
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
Group 2, RRHL: Mean Frequency of PET or PET-CT Scan Assessments for Participants Who Relapse After ASCT
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
Data for PET-CT scan and CT scans were assessed for baseline, frontline and relapse or refractory, as planned.
|
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
Group 2, RRHL: Number of Participants With Types of Radiotherapies Received at Frontline and at Relapse/Refractory in Participants Who Relapse After ASCT
Časové okno: From initial diagnosis and until death or date of data collected, whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
From initial diagnosis and until death or date of data collected, whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
|
Group 2, RRHL: Number of Participants Categorized Based on Anatomical Site of Radiotherapies in Participants Who Relapse After ASCT at Frontline and at Relapse/Refractory
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
|
Group 2, RRHL: Number of Participants Categorized Based on Intent of Treatment of Radiotherapies in Participants Who Relapse After ASCT
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
|
Group 2, RRHL: Total Dose of Radiotherapies Received at Frontline and Relapse/Refractory in Participants Who Relapse After ASCT
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
|
Group 2, RRHL: Percentage of Participants Undergoing Subsequent ASCTs and Allogeneic Stem Cell Transplantation (Allo-SCT)
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
|
Group 2, RRHL: Group 2, RRHL: Median Number of ASCTs for Each Participant Who Relapse After ASCT
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
|
Group 1, cHL: Median PFS
Časové okno: From initiation of frontline regimen to first documentation of relapse/PD/until date of death (or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
PFS was defined as time from initiation of frontline regimen to first documentation of relapse or disease progression or death, censored at date of most recent follow-up/contact.
PD was defined as any new lesion or increase by >= 50% of previously involved site from nadir, and was evaluated based on IWG criteria (Cheson et al 2007).
Median PFS was estimated using the Kaplan-Meier method.
|
From initiation of frontline regimen to first documentation of relapse/PD/until date of death (or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
Group 1, cHL: Number of Participants Based on Best Clinical Response Post Completion of Frontline Treatment
Časové okno: From post completion of frontline treatment until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
Best clinical response as complete remission (CR), partial remission (PR), stable disease (SD), or PD was evaluated based on IWG criteria (Cheson et al 2007).
CR was the disappearance of all evidence of disease.
PR was the regression of measurable disease and no new sites.
SD was defined by failure to achieve CR, PR, or PD.
PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir.
|
From post completion of frontline treatment until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment
Časové okno: From post completion of frontline treatment until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
Best clinical response as CR, PR, SD, or PD was evaluated based on IWG criteria (Cheson et al 2007).
CR was the disappearance of all evidence of disease.
PR was the regression of measurable disease and no new sites.
SD was defined by failure to achieve CR, PR, or PD.
PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir.
|
From post completion of frontline treatment until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
Mean Duration of Best Response
Časové okno: From CR or PR until first documentation of relapse or disease progression or until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
Duration of best response was defined as the time from when the criteria for response (CR or PR) were met to first documentation of relapse or disease progression, and was evaluated based on IWG criteria (Cheson et al 2007).
CR was the disappearance of all evidence of disease.
PR was the regression of measurable disease and no new sites.
PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir.
|
From CR or PR until first documentation of relapse or disease progression or until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
Median Overall Survival (OS)
Časové okno: From initial diagnosis until the date of death (or date when the participant was alive) (Group 1); From first relapse after frontline therapy to death (Group 2) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
Median OS was defined as the time from diagnosis of cHL to death(Group 1)/ time from first relapse after frontline therapy to death (Group 2), censored at date of most recent follow-up/contact.
|
From initial diagnosis until the date of death (or date when the participant was alive) (Group 1); From first relapse after frontline therapy to death (Group 2) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
Group 1, cHL: Overall Survival Rate After Diagnosis at 1 and 5 Years
Časové okno: At 1 year and 5 years after diagnosis (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
Percentage of participants who were alive at 1 and 5 years after diagnosis in cHL participants are reported.
5 year overall survival data were reported only for participants who had >5 year observation periods.
|
At 1 year and 5 years after diagnosis (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
Group 2, RRHL: Overall Survival Rate at 1 and 5 Years
Časové okno: At 1 year and 5 years after relapse (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
Percentage of participants who were alive at 1 and 5 years after diagnosis in RRHL participants are reported.
5 year overall survival data were reported only for participants who had >5 year observation periods.
|
At 1 year and 5 years after relapse (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
Group 1, cHL: Number of Participants Who Had Inpatient Hospital Admissions, Emergency Room Visits, and Outpatient Visits by Healthcare Professionals Related to HL
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
|
Group 1, cHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
|
Group 1, cHL: Mean Overall Length of Stay and Length of Stay by Unit/Ward for Inpatient Hospital Admissions Related to HL
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
Length of stay by unit or ward included general, high dependency/intermediate, intensive care unit, bone marrow transplant unit, and emergency visits.
|
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
Group 1, cHL: Number of Participants Categorized Based on Episodes of RT Received, Type of Scan or Procedure, and Who Received Granulocyte-colony Stimulating Factor (G-CSF) or High-cost Medicines and Pegylated G-CSF Related to HL
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
|
Group 1, cHL: Mean Number of Courses of Treatment With G-CSF/Pegylated G-CSF or Other High-cost Medicines Related to HL Treatment
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
|
Group 2, RRHL: Number of Participants Who Had Inpatient Hospital Admissions, Emergency Room Visits, and Outpatient Visits by Healthcare Professional Related to HL for Salvage Therapy and ASCT
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
Each participant had more than one category presented for salvage therapy and ASCT.
|
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
Group 2, RRHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL for Salvage Therapy and ASCT
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
Each participant had more than one category presented for salvage therapy and ASCT.
|
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
Group 2, RRHL: Mean Overall Length of Stay and Length of Stay by Unit/Ward for Inpatient Hospital Admissions Related to HL for Salvage Therapy and ASCT
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
Length of stay by unit or ward included general, high dependency/intermediate, intensive care unit, bone marrow transplant unit, and emergency visits.
Each participant had more than one category presented for salvage therapy and ASCT.
|
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
Group 2, RRHL: Number of Participants Categorized Based on Episodes of RT, Type of Scan or Procedure, and Who Received G-CSF or High-cost Medicines Related to HL for Salvage Therapy and ASCT
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
Each participant had more than one category presented for salvage therapy and ASCT.
Scan procedures included chest x-ray, magnetic resonance imaging, needle biopsy, bone scan, bone marrow aspiration, flow cytometry, and other scan procedures.
|
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
|
Group 2, RRHL: Group 2, RRHL: Mean Number of Courses of Treatment With G-CSF/Pegylated G-CSF or Other High-cost Medicines Related to HL Treatment for Salvage Therapy and ASCT
Časové okno: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
21. listopadu 2017
Primární dokončení (Aktuální)
31. října 2019
Dokončení studie (Aktuální)
31. října 2019
Termíny zápisu do studia
První předloženo
27. října 2017
První předloženo, které splnilo kritéria kontroly kvality
27. října 2017
První zveřejněno (Aktuální)
31. října 2017
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
25. června 2021
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
3. června 2021
Naposledy ověřeno
1. června 2021
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CHL-5001
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Ano
Popis plánu IPD
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5).
These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Kritéria přístupu pro sdílení IPD
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/.
For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Typ podpůrných informací pro sdílení IPD
- Protokol studie
- Plán statistické analýzy (SAP)
- Formulář informovaného souhlasu (ICF)
- Zpráva o klinické studii (CSR)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .