TriangleNCT04099251 · STUDY IN CONTEXT
Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma
Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
Recurrence Free Survival (RFS) is defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma (including melanoma in situ), or death (whatever the cause), whichever occurs first. For participants who remain alive and whose disease has not recurred or did not die, RFS will be censored on the date of last evaluable disease assessment. For those participants who remained alive and had no recorded post-randomization tumor assessment, RFS will be censored on the day of randomization.
Investigator-assessed distant metastasis-free survival (DMFS) is defined as the time between the date of randomization and the date of first distant metastasis or date of death (whatever the cause), whichever occurs first. Participants with no baseline disease assessment, no on-study disease assessments and no death, and no distant metastasis and no death will be censored. Participants with no baseline disease assessment and no on-study disease assessments and death are censored on the date of randomization. Participants with no recurrence and no death will be censored on the date of their last evaluable disease assessment.
Duration of treatment is an investigator-assessed outcome of next-line therapy (NLT) defined as the time from first dose date of NLT to last dose date of NLT. Participants who did not stop the NLT were censored.
Progression-free survival through next-line therapy (PFS2) is defined as the time from randomization to recurrence/objective disease progression after the start of the next-line of systemic anti-cancer therapy, or to the start of a second next-line systemic therapy, or to death from any cause, whichever occurs first. Participants who did not receive subsequent systemic anti-cancer therapy who died will be considered as having the event on the date of death. Participants who received subsequent systemic anti-cancer therapy who had a disease progression after the start of therapy will be considered as having the event on the date of disease progression. Participants who died or started second next-line therapy, the date of death or start date of second next-line therapy will be the event date, whichever is earlier. Participants who did not experience disease progression, death, or second next-line therapy will be censored on the last known alive date.
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
An Adverse Event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-stage-iii-recurrent-b30c6767
- nct id
- NCT04099251
- trial label
- Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma
- applicability
- unclear
- applicability note
- Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 3
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-stage-iii-recurrent-b30c6767
- nct id
- NCT04099251
- outcome key
- om-0000
- source section id
- NCT04099251-om-0000
- source outcome index
- 0
- endpoint
- Recurrence Free Survival (RFS)
- endpoint definition
- Recurrence Free Survival (RFS) is defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma (including melanoma in situ), or death (whatever the cause), whichever occurs first. For participants who remain alive and whose disease has not recurred or did not die, RFS will be censored on the date of last evaluable disease assessment. For those participants who remained alive and had no recorded post-randomization tumor assessment, RFS will be censored on the day of randomization.
- time origin
- From randomization up to the date of first recurrence, new primary melanoma, or death (whatever the cause), whichever occurs first (up to 32 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized participants
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-stage-iii-recurrent-b30c6767
- nct id
- NCT04099251
- outcome key
- om-0001
- source section id
- NCT04099251-om-0001
- source outcome index
- 1
- endpoint
- Distant Metastasis-Free Survival (DMFS)
- endpoint definition
- Investigator-assessed distant metastasis-free survival (DMFS) is defined as the time between the date of randomization and the date of first distant metastasis or date of death (whatever the cause), whichever occurs first. Participants with no baseline disease assessment, no on-study disease assessments and no death, and no distant metastasis and no death will be censored. Participants with no baseline disease assessment and no on-study disease assessments and death are censored on the date of randomization. Participants with no recurrence and no death will be censored on the date of their last evaluable disease assessment.
- time origin
- From randomization up to the date of first distant metastasis or date of death (whatever the cause), whichever occurs first (up to approximately 32 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized participants
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-stage-iii-recurrent-b30c6767
- nct id
- NCT04099251
- outcome key
- om-0002
- source section id
- NCT04099251-om-0002
- source outcome index
- 2
- endpoint
- Duration of Treatment on Next Line Therapy Per Investigator Assessment
- endpoint definition
- Duration of treatment is an investigator-assessed outcome of next-line therapy (NLT) defined as the time from first dose date of NLT to last dose date of NLT. Participants who did not stop the NLT were censored.
- time origin
- From first dose date of next-line therapy to last dose date of next-line therapy (up to approximately 32 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized participants
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-stage-iii-recurrent-b30c6767
- nct id
- NCT04099251
- outcome key
- om-0003
- source section id
- NCT04099251-om-0003
- source outcome index
- 3
- endpoint
- Progression-Free Survival Through Next-Line Therapy
- endpoint definition
- Progression-free survival through next-line therapy (PFS2) is defined as the time from randomization to recurrence/objective disease progression after the start of the next-line of systemic anti-cancer therapy, or to the start of a second next-line systemic therapy, or to death from any cause, whichever occurs first. Participants who did not receive subsequent systemic anti-cancer therapy who died will be considered as having the event on the date of death. Participants who received subsequent systemic anti-cancer therapy who had a disease progression after the start of therapy will be considered as having the event on the date of disease progression. Participants who died or started second next-line therapy, the date of death or start date of second next-line therapy will be the event date, whichever is earlier. Participants who did not experience disease progression, death, or second next-line therapy will be censored on the last known alive date.
- time origin
- From randomization to recurrence/objective disease progression after the start of the next-line therapy, or to the start of a second next-line systemic therapy, or to death from any cause, whichever occurs first (up to approximately 32 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized participants
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-stage-iii-recurrent-b30c6767
- nct id
- NCT04099251
- outcome key
- om-0004
- source section id
- NCT04099251-om-0004
- source outcome index
- 4
- endpoint
- Number of Participants Experiencing Adverse Events (AEs)
- endpoint definition
- An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
- time origin
- From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All treated participants
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-stage-iii-recurrent-b30c6767
- nct id
- NCT04099251
- outcome key
- om-0005
- source section id
- NCT04099251-om-0005
- source outcome index
- 5
- endpoint
- Number of Participants Experiencing Adverse Events Leading to Discontinuation
- endpoint definition
- An Adverse Event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure.
- time origin
- From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All treated participants
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-stage-iii-recurrent-b30c6767
- nct id
- NCT04099251
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Nivolumab
- regimen
- Participants received 480 mg IV Nivolumab in an approximately 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. Participants began study treatment (Cycle 1) within 3 calendar days of randomization. Subsequent cycles were initiated within ± 3 days of the target visit date.
- analyzed count
- 526
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04099251-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-stage-iii-recurrent-b30c6767
- nct id
- NCT04099251
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Placebo
- regimen
- Nivolumab matched placebo (0.9% Sodium Chloride for Injection/5% Dextrose for Injection) IV in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. In the event of disease recurrence, participants on the blinded nivolumab or placebo portion will be offered the option to receive open-label on-protocol nivolumab treatment. Participants received 480 mg IV Nivolumab in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, recurrence/progression, withdrawal of consent, completion of 12 months of treatment from first dose of open-label study treatment, whichever occurred first.
- analyzed count
- 264
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04099251-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-stage-iii-recurrent-b30c6767
- nct id
- NCT04099251
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Nivolumab
- regimen
- Participants received 480 mg IV Nivolumab in an approximately 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. Participants began study treatment (Cycle 1) within 3 calendar days of randomization. Subsequent cycles were initiated within ± 3 days of the target visit date.
- analyzed count
- 526
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04099251-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-stage-iii-recurrent-b30c6767
- nct id
- NCT04099251
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Placebo
- regimen
- Nivolumab matched placebo (0.9% Sodium Chloride for Injection/5% Dextrose for Injection) IV in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. In the event of disease recurrence, participants on the blinded nivolumab or placebo portion will be offered the option to receive open-label on-protocol nivolumab treatment. Participants received 480 mg IV Nivolumab in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, recurrence/progression, withdrawal of consent, completion of 12 months of treatment from first dose of open-label study treatment, whichever occurred first.
- analyzed count
- 264
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04099251-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-stage-iii-recurrent-b30c6767
- nct id
- NCT04099251
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Nivolumab
- regimen
- Participants received 480 mg IV Nivolumab in an approximately 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. Participants began study treatment (Cycle 1) within 3 calendar days of randomization. Subsequent cycles were initiated within ± 3 days of the target visit date.
- analyzed count
- 526
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04099251-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-stage-iii-recurrent-b30c6767
- nct id
- NCT04099251
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Placebo
- regimen
- Nivolumab matched placebo (0.9% Sodium Chloride for Injection/5% Dextrose for Injection) IV in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. In the event of disease recurrence, participants on the blinded nivolumab or placebo portion will be offered the option to receive open-label on-protocol nivolumab treatment. Participants received 480 mg IV Nivolumab in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, recurrence/progression, withdrawal of consent, completion of 12 months of treatment from first dose of open-label study treatment, whichever occurred first.
- analyzed count
- 264
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04099251-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-stage-iii-recurrent-b30c6767
- nct id
- NCT04099251
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Nivolumab
- regimen
- Participants received 480 mg IV Nivolumab in an approximately 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. Participants began study treatment (Cycle 1) within 3 calendar days of randomization. Subsequent cycles were initiated within ± 3 days of the target visit date.
- analyzed count
- 526
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04099251-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-stage-iii-recurrent-b30c6767
- nct id
- NCT04099251
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Placebo
- regimen
- Nivolumab matched placebo (0.9% Sodium Chloride for Injection/5% Dextrose for Injection) IV in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. In the event of disease recurrence, participants on the blinded nivolumab or placebo portion will be offered the option to receive open-label on-protocol nivolumab treatment. Participants received 480 mg IV Nivolumab in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, recurrence/progression, withdrawal of consent, completion of 12 months of treatment from first dose of open-label study treatment, whichever occurred first.
- analyzed count
- 264
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04099251-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-stage-iii-recurrent-b30c6767
- nct id
- NCT04099251
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Nivolumab
- regimen
- Participants received 480 mg IV Nivolumab in an approximately 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. Participants began study treatment (Cycle 1) within 3 calendar days of randomization. Subsequent cycles were initiated within ± 3 days of the target visit date.
- analyzed count
- 524
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04099251-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-stage-iii-recurrent-b30c6767
- nct id
- NCT04099251
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Placebo
- regimen
- Nivolumab matched placebo (0.9% Sodium Chloride for Injection/5% Dextrose for Injection) IV in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. In the event of disease recurrence, participants on the blinded nivolumab or placebo portion will be offered the option to receive open-label on-protocol nivolumab treatment. Participants received 480 mg IV Nivolumab in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, recurrence/progression, withdrawal of consent, completion of 12 months of treatment from first dose of open-label study treatment, whichever occurred first.
- analyzed count
- 264
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04099251-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-stage-iii-recurrent-b30c6767
- nct id
- NCT04099251
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Nivolumab
- regimen
- Participants received 480 mg IV Nivolumab in an approximately 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. Participants began study treatment (Cycle 1) within 3 calendar days of randomization. Subsequent cycles were initiated within ± 3 days of the target visit date.
- analyzed count
- 524
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04099251-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-stage-iii-recurrent-b30c6767
- nct id
- NCT04099251
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Placebo
- regimen
- Nivolumab matched placebo (0.9% Sodium Chloride for Injection/5% Dextrose for Injection) IV in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. In the event of disease recurrence, participants on the blinded nivolumab or placebo portion will be offered the option to receive open-label on-protocol nivolumab treatment. Participants received 480 mg IV Nivolumab in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, recurrence/progression, withdrawal of consent, completion of 12 months of treatment from first dose of open-label study treatment, whichever occurred first.
- analyzed count
- 264
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04099251-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-stage-iii-recurrent-b30c6767
- nct id
- NCT04099251
- harm key
- EG000
- source section id
- NCT04099251-ae
- event group key
- EG000
- event group label
- Nivolumab
- serious affected
- 95
- serious at risk
- 524
- other affected
- 464
- other at risk
- 524
- frequency threshold
- 5
- collection period
- Participants were assessed for all-cause mortality from their randomization to primary completion, (up to approximately 32 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 32 months)
- event definition
- The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-stage-iii-recurrent-b30c6767
- nct id
- NCT04099251
- harm key
- EG001
- source section id
- NCT04099251-ae
- event group key
- EG001
- event group label
- Placebo
- serious affected
- 37
- serious at risk
- 264
- other affected
- 194
- other at risk
- 264
- frequency threshold
- 5
- collection period
- Participants were assessed for all-cause mortality from their randomization to primary completion, (up to approximately 32 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 32 months)
- event definition
- The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-stage-iii-recurrent-b30c6767
- nct id
- NCT04099251
- harm key
- EG002
- source section id
- NCT04099251-ae
- event group key
- EG002
- event group label
- Open-Label Nivolumab
- serious affected
- 5
- serious at risk
- 30
- other affected
- 20
- other at risk
- 30
- frequency threshold
- 5
- collection period
- Participants were assessed for all-cause mortality from their randomization to primary completion, (up to approximately 32 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 32 months)
- event definition
- The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice