Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated I

Draft scope assessment: unclear. Attached because the study's own record describes metastatic 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

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

primary · POSTED

This measure looks at how long participants who cannot receive cisplatin (a type of chemotherapy) live after being placed into a treatment group in the primary study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization. This helps to understand if the treatment can help people who are unable to receive cisplatin chemotherapy live longer.

All Cisplatin-ineligible Randomized Participants - Primary Study

→

primary · POSTED

This measure looks at how long participants with PD-L1 positive tumors (meaning their tumor cells have at least 1% PD-L1, as determined by a laboratory test called immunohistochemistry or IHC) live after being placed into a treatment group in the primary study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization. This helps to understand whether the treatment can help people with PD-L1 positive tumors live longer.

All PD-L1 \>= 1% Randomized Participants - Primary Study

→

secondary · POSTED

This measure looks at how long all participants live after being placed into a treatment group in the primary study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization. This helps to understand whether the treatment can help all participants in the study live longer.

All Randomized Participants - Primary Study

→

secondary · POSTED

This measure looks at how long people who cannot receive cisplatin chemotherapy live without their cancer getting worse after being assigned to a treatment group in the primary study. Progression-Free Survival (PFS) is the time from when a participant is assigned to a group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment was given. These experts use standard rules (RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check. This helps to understand if the treatment helps people unable to receive cisplatin live longer without their cancer progressing.

All Cisplatin-ineligible Randomized Participants - Primary Study

→

secondary · POSTED

This measure looks at how long people with PD-L1 positive tumors (meaning their tumor cells have at least 1% PD-L1, as determined by a lab test) live without their cancer getting worse after being assigned to a treatment group in the primary study. Progression-Free Survival (PFS) is the time from when a participant is assigned to a group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment was given. These experts use standard rules (RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check. This helps to understand if the treatment helps people with PD-L1 positive tumors live longer without their cancer progressing.

All PD-L1 \>= 1% Randomized Participants - Primary Study

→

secondary · POSTED

This measure looks at how long all participants in the primary study live without their cancer getting worse after being assigned to a treatment group. Progression-Free Survival (PFS) is defined as the time from when a participant is assigned to a treatment group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment the participant received. These experts use standard rules (called RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check. This helps to understand whether the treatment can help participants live longer without their cancer progressing.

All Randomized Participants - Primary Study

→

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

EORTC QLQ · Change From Baseline in the European Organization for Research and Treatment of Care Quality-of-Life Questionnaire (EORTC QLQ-C30) Global Health Status Score in All Randomized Participants for Primary Study

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-urothelial-carcinoma-imfinzi-92d35647
nct id: NCT03036098
qol key: qol-0006
source section id: NCT03036098-om-0006
source outcome index: 6
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: Change From Baseline in the European Organization for Research and Treatment of Care Quality-of-Life Questionnaire (EORTC QLQ-C30) Global Health Status Score in All Randomized Participants for Primary Study
measure definition: The EORTC QLQ-C30 is a questionnaire used to assess the quality of life in cancer patients. It includes a global health status score, which is measured on a 4-point Likert scale: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much. Responses are combined and converted to scores ranging from 0 to 100. A high score for global health status or health-related quality of life (HRQoL) indicates a high overall HRQoL.
time frame: At Baseline, Week 4, Week 10, Week 16, Week 20, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 108, Week 120, Week 144, Week 156, Week 168, Week 180 and Week 192
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: All Randomized Participants - Primary Study
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

EORTC QLQ · Change From Baseline in the European Organization for Research and Treatment of Care Quality-of-Life Questionnaire (EORTC QLQ-C30) Global Health Status Score for Sub-study

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-urothelial-carcinoma-imfinzi-92d35647
nct id: NCT03036098
qol key: qol-0009
source section id: NCT03036098-om-0009
source outcome index: 9
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: Change From Baseline in the European Organization for Research and Treatment of Care Quality-of-Life Questionnaire (EORTC QLQ-C30) Global Health Status Score for Sub-study
measure definition: The EORTC QLQ-C30 is a questionnaire used to assess the quality of life in cancer patients. It includes a global health status score, which is measured on a 4-point Likert scale: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much. Responses are combined and converted to scores ranging from 0 to 100. A high score for global health status or health-related quality of life (HRQoL) indicates a high overall HRQoL.
time frame: At Baseline, Week 4, Week 10, Week 16, Week 20, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 108, and Week 120
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: All Randomized Participants - Sub-study
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-urothelial-carcinoma-imfinzi-92d35647
nct id: NCT03036098
trial label: Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated I
applicability: unclear
applicability note: Attached because the study's own record describes metastatic 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: 4
qol Count: 2

outcomes

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT03036098
outcome key
om-0000
source section id
NCT03036098-om-0000
source outcome index
0
endpoint
Overall Survival (OS) in Cisplatin-ineligible Randomized Participants for Primary Study
endpoint definition
This measure looks at how long participants who cannot receive cisplatin (a type of chemotherapy) live after being placed into a treatment group in the primary study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization. This helps to understand if the treatment can help people who are unable to receive cisplatin chemotherapy live longer.
time origin
From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All Cisplatin-ineligible Randomized Participants - Primary Study
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-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT03036098
outcome key
om-0001
source section id
NCT03036098-om-0001
source outcome index
1
endpoint
Overall Survival (OS) in Programmed Death-Ligand 1 (PD-L1) Positive (≥ 1%) Randomized Participants by Immunohistochemistry (IHC) for Primary Study
endpoint definition
This measure looks at how long participants with PD-L1 positive tumors (meaning their tumor cells have at least 1% PD-L1, as determined by a laboratory test called immunohistochemistry or IHC) live after being placed into a treatment group in the primary study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization. This helps to understand whether the treatment can help people with PD-L1 positive tumors live longer.
time origin
From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All PD-L1 \>= 1% Randomized Participants - Primary Study
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-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT03036098
outcome key
om-0002
source section id
NCT03036098-om-0002
source outcome index
2
endpoint
Overall Survival (OS) in All Randomized Participants for Primary Study
endpoint definition
This measure looks at how long all participants live after being placed into a treatment group in the primary study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization. This helps to understand whether the treatment can help all participants in the study live longer.
time origin
From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All Randomized Participants - Primary Study
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-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT03036098
outcome key
om-0003
source section id
NCT03036098-om-0003
source outcome index
3
endpoint
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Cisplatin-ineligible Randomized Participants for Primary Study
endpoint definition
This measure looks at how long people who cannot receive cisplatin chemotherapy live without their cancer getting worse after being assigned to a treatment group in the primary study. Progression-Free Survival (PFS) is the time from when a participant is assigned to a group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment was given. These experts use standard rules (RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check. This helps to understand if the treatment helps people unable to receive cisplatin live longer without their cancer progressing.
time origin
From the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All Cisplatin-ineligible Randomized Participants - Primary Study
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-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT03036098
outcome key
om-0004
source section id
NCT03036098-om-0004
source outcome index
4
endpoint
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Programmed Death-Ligand 1 (PD-L1) Positive (≥ 1%) Participants for Primary Study
endpoint definition
This measure looks at how long people with PD-L1 positive tumors (meaning their tumor cells have at least 1% PD-L1, as determined by a lab test) live without their cancer getting worse after being assigned to a treatment group in the primary study. Progression-Free Survival (PFS) is the time from when a participant is assigned to a group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment was given. These experts use standard rules (RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check. This helps to understand if the treatment helps people with PD-L1 positive tumors live longer without their cancer progressing.
time origin
From the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All PD-L1 \>= 1% Randomized Participants - Primary Study
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-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT03036098
outcome key
om-0005
source section id
NCT03036098-om-0005
source outcome index
5
endpoint
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in All Randomized Participants for Primary Study
endpoint definition
This measure looks at how long all participants in the primary study live without their cancer getting worse after being assigned to a treatment group. Progression-Free Survival (PFS) is defined as the time from when a participant is assigned to a treatment group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment the participant received. These experts use standard rules (called RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check. This helps to understand whether the treatment can help participants live longer without their cancer progressing.
time origin
From the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All Randomized Participants - Primary Study
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-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT03036098
outcome key
om-0000
arm key
OG000
arm label
Treatment 1
regimen
Participants received Nivolumab 1 mg/kg plus Ipilimumab 3 mg/kg every three weeks (Q3W) for up to 4 doses followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Primary Study
analyzed count
221
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03036098-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT03036098
outcome key
om-0000
arm key
OG001
arm label
Treatment 2
regimen
Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Primary Study
analyzed count
224
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03036098-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT03036098
outcome key
om-0001
arm key
OG000
arm label
Treatment 1
regimen
Participants received Nivolumab 1 mg/kg plus Ipilimumab 3 mg/kg every three weeks (Q3W) for up to 4 doses followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Primary Study
analyzed count
123
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03036098-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT03036098
outcome key
om-0001
arm key
OG001
arm label
Treatment 2
regimen
Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Primary Study
analyzed count
127
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03036098-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT03036098
outcome key
om-0002
arm key
OG000
arm label
Treatment 1
regimen
Participants received Nivolumab 1 mg/kg plus Ipilimumab 3 mg/kg every three weeks (Q3W) for up to 4 doses followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Primary Study
analyzed count
349
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03036098-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT03036098
outcome key
om-0002
arm key
OG001
arm label
Treatment 2
regimen
Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Primary Study
analyzed count
357
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03036098-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT03036098
outcome key
om-0003
arm key
OG000
arm label
Treatment 1
regimen
Participants received Nivolumab 1 mg/kg plus Ipilimumab 3 mg/kg every three weeks (Q3W) for up to 4 doses followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Primary Study
analyzed count
221
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03036098-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT03036098
outcome key
om-0003
arm key
OG001
arm label
Treatment 2
regimen
Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Primary Study
analyzed count
224
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03036098-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT03036098
outcome key
om-0004
arm key
OG000
arm label
Treatment 1
regimen
Participants received Nivolumab 1 mg/kg plus Ipilimumab 3 mg/kg every three weeks (Q3W) for up to 4 doses followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Primary Study
analyzed count
123
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03036098-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT03036098
outcome key
om-0004
arm key
OG001
arm label
Treatment 2
regimen
Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Primary Study
analyzed count
127
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03036098-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT03036098
outcome key
om-0005
arm key
OG000
arm label
Treatment 1
regimen
Participants received Nivolumab 1 mg/kg plus Ipilimumab 3 mg/kg every three weeks (Q3W) for up to 4 doses followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Primary Study
analyzed count
349
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03036098-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT03036098
outcome key
om-0005
arm key
OG001
arm label
Treatment 2
regimen
Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Primary Study
analyzed count
357
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03036098-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT03036098
harm key
EG000
source section id
NCT03036098-ae
event group key
EG000
event group label
Treatment 1
serious affected
264
serious at risk
345
other affected
322
other at risk
345
frequency threshold
5
collection period
Participants were assessed for All-Cause Mortality from the date of randomization until primary study completion. SAEs and Other AEs were assessed from first dose of study medication until primary study completion (assessed up to approximately 89 months).
event definition
All-Cause Mortality represents all randomized participants. 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-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT03036098
harm key
EG001
source section id
NCT03036098-ae
event group key
EG001
event group label
Treatment 2
serious affected
170
serious at risk
328
other affected
309
other at risk
328
frequency threshold
5
collection period
Participants were assessed for All-Cause Mortality from the date of randomization until primary study completion. SAEs and Other AEs were assessed from first dose of study medication until primary study completion (assessed up to approximately 89 months).
event definition
All-Cause Mortality represents all randomized participants. 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-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT03036098
harm key
EG002
source section id
NCT03036098-ae
event group key
EG002
event group label
Treatment 3
serious affected
168
serious at risk
304
other affected
298
other at risk
304
frequency threshold
5
collection period
Participants were assessed for All-Cause Mortality from the date of randomization until primary study completion. SAEs and Other AEs were assessed from first dose of study medication until primary study completion (assessed up to approximately 89 months).
event definition
All-Cause Mortality represents all randomized participants. 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-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT03036098
harm key
EG003
source section id
NCT03036098-ae
event group key
EG003
event group label
Treatment 4
serious affected
130
serious at risk
301
other affected
295
other at risk
301
frequency threshold
5
collection period
Participants were assessed for All-Cause Mortality from the date of randomization until primary study completion. SAEs and Other AEs were assessed from first dose of study medication until primary study completion (assessed up to approximately 89 months).
event definition
All-Cause Mortality represents all randomized participants. 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

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT03036098
qol key
qol-0006
source section id
NCT03036098-om-0006
source outcome index
6
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline in the European Organization for Research and Treatment of Care Quality-of-Life Questionnaire (EORTC QLQ-C30) Global Health Status Score in All Randomized Participants for Primary Study
measure definition
The EORTC QLQ-C30 is a questionnaire used to assess the quality of life in cancer patients. It includes a global health status score, which is measured on a 4-point Likert scale: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much. Responses are combined and converted to scores ranging from 0 to 100. A high score for global health status or health-related quality of life (HRQoL) indicates a high overall HRQoL.
time frame
At Baseline, Week 4, Week 10, Week 16, Week 20, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 108, Week 120, Week 144, Week 156, Week 168, Week 180 and Week 192
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
All Randomized Participants - Primary Study
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-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT03036098
qol key
qol-0009
source section id
NCT03036098-om-0009
source outcome index
9
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline in the European Organization for Research and Treatment of Care Quality-of-Life Questionnaire (EORTC QLQ-C30) Global Health Status Score for Sub-study
measure definition
The EORTC QLQ-C30 is a questionnaire used to assess the quality of life in cancer patients. It includes a global health status score, which is measured on a 4-point Likert scale: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much. Responses are combined and converted to scores ranging from 0 to 100. A high score for global health status or health-related quality of life (HRQoL) indicates a high overall HRQoL.
time frame
At Baseline, Week 4, Week 10, Week 16, Week 20, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 108, and Week 120
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
All Randomized Participants - Sub-study
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

setting source links

Preserved source evidence · Not medical advice