NCT04003636 · STUDY IN CONTEXT

Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Overall survival was defined as the time from randomization to death due to any cause.

All randomized participants

→

secondary · POSTED

PFS was defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by BICR per RECIST 1.1 was presented.

All randomized participants

→

secondary · POSTED

ORR was defined as the percentage of participants who have a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: a ≥30% decrease in the sum of diameters \[SOD\] of target lesions) as assessed by BICR per RECIST 1.1, which was adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ.

All randomized participants

→

secondary · POSTED

For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until PD or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR with confirmation. The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR was presented.

All randomized participants with CR or PR

→

secondary · POSTED

An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. Number of participants who experienced one or more AEs were reported.

All Participants as Treated (APaT) population, which consisted of all randomized participants who received at least 1 dose of study intervention

→

secondary · POSTED

An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurs during the course of the study. Number of participants who discontinued study intervention due to an AE were reported.

All Participants as Treated (APaT) population, which consisted of all randomized participants who received at least 1 dose of study intervention.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

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-malignant-biliary-tract-neoplasm
nct id: NCT04003636
trial label: Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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-malignant-biliary-tract-neoplasm
nct id
NCT04003636
outcome key
om-0000
source section id
NCT04003636-om-0000
source outcome index
0
endpoint
Overall Survival (OS)
endpoint definition
Overall survival was defined as the time from randomization to death due to any cause.
time origin
Up to approximately 38 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-malignant-biliary-tract-neoplasm
nct id
NCT04003636
outcome key
om-0001
source section id
NCT04003636-om-0001
source outcome index
1
endpoint
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (BICR)
endpoint definition
PFS was defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by BICR per RECIST 1.1 was presented.
time origin
Up to approximately 26 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-malignant-biliary-tract-neoplasm
nct id
NCT04003636
outcome key
om-0002
source section id
NCT04003636-om-0002
source outcome index
2
endpoint
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
endpoint definition
ORR was defined as the percentage of participants who have a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: a ≥30% decrease in the sum of diameters \[SOD\] of target lesions) as assessed by BICR per RECIST 1.1, which was adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ.
time origin
Up to approximately 26 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-malignant-biliary-tract-neoplasm
nct id
NCT04003636
outcome key
om-0003
source section id
NCT04003636-om-0003
source outcome index
3
endpoint
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
endpoint definition
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until PD or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR with confirmation. The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR was presented.
time origin
Up to approximately 38 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All randomized participants with CR or PR
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-malignant-biliary-tract-neoplasm
nct id
NCT04003636
outcome key
om-0004
source section id
NCT04003636-om-0004
source outcome index
4
endpoint
Number of Participants Who Experience One or More Adverse Events (AE)
endpoint definition
An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. Number of participants who experienced one or more AEs were reported.
time origin
Up to approximately 65 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All Participants as Treated (APaT) population, which consisted of all randomized participants who received at least 1 dose of study intervention
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-malignant-biliary-tract-neoplasm
nct id
NCT04003636
outcome key
om-0005
source section id
NCT04003636-om-0005
source outcome index
5
endpoint
Number of Participants Who Discontinued Study Intervention Due to an AE
endpoint definition
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurs during the course of the study. Number of participants who discontinued study intervention due to an AE were reported.
time origin
Up to approximately 63 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All Participants as Treated (APaT) population, which consisted of all randomized participants who received at least 1 dose of study intervention.
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-malignant-biliary-tract-neoplasm
nct id
NCT04003636
outcome key
om-0000
arm key
OG000
arm label
Arm A: Pembrolizumab + Chemotherapy
regimen
Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.
analyzed count
533
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04003636-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-biliary-tract-neoplasm
nct id
NCT04003636
outcome key
om-0000
arm key
OG001
arm label
Arm B: Placebo + Chemotherapy
regimen
Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.
analyzed count
536
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04003636-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-malignant-biliary-tract-neoplasm
nct id
NCT04003636
outcome key
om-0001
arm key
OG000
arm label
Arm A: Pembrolizumab + Chemotherapy
regimen
Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.
analyzed count
533
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04003636-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-biliary-tract-neoplasm
nct id
NCT04003636
outcome key
om-0001
arm key
OG001
arm label
Arm B: Placebo + Chemotherapy
regimen
Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.
analyzed count
536
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04003636-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-malignant-biliary-tract-neoplasm
nct id
NCT04003636
outcome key
om-0002
arm key
OG000
arm label
Arm A: Pembrolizumab + Chemotherapy
regimen
Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.
analyzed count
533
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04003636-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-biliary-tract-neoplasm
nct id
NCT04003636
outcome key
om-0002
arm key
OG001
arm label
Arm B: Placebo + Chemotherapy
regimen
Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.
analyzed count
536
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04003636-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-malignant-biliary-tract-neoplasm
nct id
NCT04003636
outcome key
om-0003
arm key
OG000
arm label
Arm A: Pembrolizumab + Chemotherapy
regimen
Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.
analyzed count
153
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04003636-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-biliary-tract-neoplasm
nct id
NCT04003636
outcome key
om-0003
arm key
OG001
arm label
Arm B: Placebo + Chemotherapy
regimen
Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.
analyzed count
153
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04003636-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-malignant-biliary-tract-neoplasm
nct id
NCT04003636
outcome key
om-0004
arm key
OG000
arm label
Arm A: Pembrolizumab + Chemotherapy
regimen
Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.
analyzed count
529
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04003636-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-biliary-tract-neoplasm
nct id
NCT04003636
outcome key
om-0004
arm key
OG001
arm label
Arm B: Placebo + Chemotherapy
regimen
Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.
analyzed count
534
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04003636-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-malignant-biliary-tract-neoplasm
nct id
NCT04003636
outcome key
om-0005
arm key
OG000
arm label
Arm A: Pembrolizumab + Chemotherapy
regimen
Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.
analyzed count
529
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04003636-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-biliary-tract-neoplasm
nct id
NCT04003636
outcome key
om-0005
arm key
OG001
arm label
Arm B: Placebo + Chemotherapy
regimen
Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.
analyzed count
534
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04003636-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-malignant-biliary-tract-neoplasm
nct id
NCT04003636
harm key
EG000
source section id
NCT04003636-ae
event group key
EG000
event group label
First Course: Arm A: Pembrolizumab + Chemotherapy
serious affected
280
serious at risk
529
other affected
513
other at risk
529
frequency threshold
5
collection period
Up to approximately 65 months
event definition
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
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-malignant-biliary-tract-neoplasm
nct id
NCT04003636
harm key
EG001
source section id
NCT04003636-ae
event group key
EG001
event group label
First Course: Arm B: Placebo + Chemotherapy
serious affected
264
serious at risk
534
other affected
522
other at risk
534
frequency threshold
5
collection period
Up to approximately 65 months
event definition
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
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-malignant-biliary-tract-neoplasm
nct id
NCT04003636
harm key
EG002
source section id
NCT04003636-ae
event group key
EG002
event group label
Second Course: Arm A: Pembrolizumab + Chemotherapy
serious affected
0
serious at risk
10
other affected
10
other at risk
10
frequency threshold
5
collection period
Up to approximately 65 months
event definition
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
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