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← Opdivo: metastatic Urothelial carcinoma (neoadjuvant) after prior therapy

NCT02426125 · STUDY IN CONTEXT

A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial Cancer

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 by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

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

PFS defined as time from first day of therapy to first evidence of disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause. Progressive Disease (PD) is at least 20% increase in sum of diameters of target lesions, with reference being the smallest sum on study and plus absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If participant does not have complete baseline disease assessment, then PFS time was censored at date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for participant. If participant is not known to have died or have objective progression as of data inclusion cutoff date for analysis, PFS time was censored at last adequate tumor assessment date.

The first randomized participants. Censored participants: Ramucirumab + Docetaxel = 58, Placebo + Docetaxel =38.

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secondary · POSTED

OS is the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data inclusion cutoff date for a particular analysis, OS was censored for that analysis at the last known alive date prior to the data inclusion cutoff date.

All randomized participants. Censored participants: Ramucirumab + Docetaxel = 78, Placebo + Docetaxel = 67.

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secondary · POSTED

ORR is defined as the percentage of participants who achieve a best overall response of complete response (CR) + partial response (PR). ORR = CR + PR. CR is defined as disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 millimeter (mm). Tumor-marker results must have normalized. PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Best overall response is classified based on the overall responses assessed by study investigators according to RECIST v1.1.

All randomized participants.

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secondary · POSTED

DCR is the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1. Target lesions - CR: Disappearance of all lesions; any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum. Progressive Disease (PD): At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non target lesions - CR: Disappearance of all lesions and normalization of tumor marker levels; all lymph nodes must be non-pathological in size. Non-CR/Non-PD: Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels. PD: Unequivocal progression of existing lesions or the appearance of new lesion(s).

All randomized participants.

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secondary · POSTED

Objective response was achieved if they had a best overall response of CR or PR. Target lesions- CR: Disappearance of all lesions; any pathological lymph nodes have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum. PD: At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study(the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Non target lesions - CR: Disappearance of all lesions and normalization of tumour marker levels; all lymph nodes must be non-pathological in size. Non-CR/Non-PD: Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels. PD: Unequivocal progression of existing lesions or the appearance of new lesion(s). If a participant was not known to have died or have radiographically documented PD as of the data inclusion cutoff date, DOR was censored at the date of the last adequate tumor assessment.

All randomized participants with CR or PR. Participants censored in Ramucirumab + Docetaxel = 12 and in Placebo + Docetaxel = 5.

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secondary · POSTED

Time to sustained deterioration was defined as time from randomization to first worsening in QoL with no subsequent non-worsened assessment. Worsening in global health status/QoL was defined as a decrease of ≥10 points on a 100-point scale. If a participant did not report worsening, time to sustained deterioration was censored at date of last non-worsened assessment. Scores for global health status/QoL range from 0 to 100 with; higher scores representing better QoL.

All randomized participants. Censored participants: Ramucirumab + Docetaxel = 160, Placebo + Docetaxel = 173.

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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 · Time to Deterioration in Quality of Life (QoL) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status/ QoL Scale

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02426125
qol key
qol-0005
source section id
NCT02426125-om-0005
source outcome index
5
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Time to Deterioration in Quality of Life (QoL) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status/ QoL Scale
measure definition
Time to sustained deterioration was defined as time from randomization to first worsening in QoL with no subsequent non-worsened assessment. Worsening in global health status/QoL was defined as a decrease of ≥10 points on a 100-point scale. If a participant did not report worsening, time to sustained deterioration was censored at date of last non-worsened assessment. Scores for global health status/QoL range from 0 to 100 with; higher scores representing better QoL.
time frame
Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months)
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher scores representing better
population note
All randomized participants. Censored participants: Ramucirumab + Docetaxel = 160, Placebo + Docetaxel = 173.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score

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-opdivo-432072c9
nct id
NCT02426125
qol key
qol-0006
source section id
NCT02426125-om-0006
source outcome index
6
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
measure definition
The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Participants completed the 5-level (no problem, slight problem, moderate problem, severe problem, and inability or extreme problem), 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire concerning their current health state. A unique EQ-5D health state is defined by combining 1 level from each of the 5 dimensions. Scores range from 0 (death) to 1 (perfect health), but scores \<0 are possible based on the algorithm.
time frame
Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
All randomized participants with baseline and 30-day follow-up data.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS)

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-opdivo-432072c9
nct id
NCT02426125
qol key
qol-0007
source section id
NCT02426125-om-0007
source outcome index
7
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS)
measure definition
The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. A unique EQ-5D health state is defined by combining 1 level from each of the 5 dimensions. Participants indicated their current health status by marking on a VAS ranging from 100 (best imaginable health state) to 0 (worst imaginable health state).
time frame
Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
All randomized participants with baseline and 30-day follow-up data.
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-opdivo-432072c9
nct id
NCT02426125
trial label
A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial Cancer
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
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
6
harms Count
2
qol Count
3
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-opdivo-432072c9
    nct id
    NCT02426125
    outcome key
    om-0000
    source section id
    NCT02426125-om-0000
    source outcome index
    0
    endpoint
    Progression Free Survival (PFS)
    endpoint definition
    PFS defined as time from first day of therapy to first evidence of disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause. Progressive Disease (PD) is at least 20% increase in sum of diameters of target lesions, with reference being the smallest sum on study and plus absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If participant does not have complete baseline disease assessment, then PFS time was censored at date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for participant. If participant is not known to have died or have objective progression as of data inclusion cutoff date for analysis, PFS time was censored at last adequate tumor assessment date.
    time origin
    Randomization to Radiological Disease Progression or Death from Any Cause (Up to 18 Months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The first randomized participants. Censored participants: Ramucirumab + Docetaxel = 58, Placebo + Docetaxel =38.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-opdivo-432072c9
    nct id
    NCT02426125
    outcome key
    om-0001
    source section id
    NCT02426125-om-0001
    source outcome index
    1
    endpoint
    Overall Survival (OS)
    endpoint definition
    OS is the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data inclusion cutoff date for a particular analysis, OS was censored for that analysis at the last known alive date prior to the data inclusion cutoff date.
    time origin
    Randomization to Date of Death from Any Cause (Up to 31.1 Months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized participants. Censored participants: Ramucirumab + Docetaxel = 78, Placebo + Docetaxel = 67.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-opdivo-432072c9
    nct id
    NCT02426125
    outcome key
    om-0002
    source section id
    NCT02426125-om-0002
    source outcome index
    2
    endpoint
    Percentage of Participants With an Objective Response Rate (ORR)
    endpoint definition
    ORR is defined as the percentage of participants who achieve a best overall response of complete response (CR) + partial response (PR). ORR = CR + PR. CR is defined as disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 millimeter (mm). Tumor-marker results must have normalized. PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Best overall response is classified based on the overall responses assessed by study investigators according to RECIST v1.1.
    time origin
    Randomization to Disease Progression (Up to 29.7 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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-opdivo-432072c9
    nct id
    NCT02426125
    outcome key
    om-0003
    source section id
    NCT02426125-om-0003
    source outcome index
    3
    endpoint
    Percentage of Participants With Disease Control Rate (DCR)
    endpoint definition
    DCR is the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1. Target lesions - CR: Disappearance of all lesions; any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum. Progressive Disease (PD): At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non target lesions - CR: Disappearance of all lesions and normalization of tumor marker levels; all lymph nodes must be non-pathological in size. Non-CR/Non-PD: Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels. PD: Unequivocal progression of existing lesions or the appearance of new lesion(s).
    time origin
    Randomization to Disease Progression (Up to 29.7 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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-opdivo-432072c9
    nct id
    NCT02426125
    outcome key
    om-0004
    source section id
    NCT02426125-om-0004
    source outcome index
    4
    endpoint
    Duration of Response (DoR)
    endpoint definition
    Objective response was achieved if they had a best overall response of CR or PR. Target lesions- CR: Disappearance of all lesions; any pathological lymph nodes have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum. PD: At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study(the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Non target lesions - CR: Disappearance of all lesions and normalization of tumour marker levels; all lymph nodes must be non-pathological in size. Non-CR/Non-PD: Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels. PD: Unequivocal progression of existing lesions or the appearance of new lesion(s). If a participant was not known to have died or have radiographically documented PD as of the data inclusion cutoff date, DOR was censored at the date of the last adequate tumor assessment.
    time origin
    Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up to 28.4 Months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized participants with CR or PR. Participants censored in Ramucirumab + Docetaxel = 12 and in Placebo + Docetaxel = 5.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-opdivo-432072c9
    nct id
    NCT02426125
    outcome key
    om-0005
    source section id
    NCT02426125-om-0005
    source outcome index
    5
    endpoint
    Time to Deterioration in Quality of Life (QoL) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status/ QoL Scale
    endpoint definition
    Time to sustained deterioration was defined as time from randomization to first worsening in QoL with no subsequent non-worsened assessment. Worsening in global health status/QoL was defined as a decrease of ≥10 points on a 100-point scale. If a participant did not report worsening, time to sustained deterioration was censored at date of last non-worsened assessment. Scores for global health status/QoL range from 0 to 100 with; higher scores representing better QoL.
    time origin
    Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized participants. Censored participants: Ramucirumab + Docetaxel = 160, Placebo + Docetaxel = 173.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-opdivo-432072c9
    nct id
    NCT02426125
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Ramucirumab + Docetaxel
    regimen
    Ramucirumab (10 mg/kg) IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
    analyzed count
    216
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02426125-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-opdivo-432072c9
    nct id
    NCT02426125
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Placebo + Docetaxel
    regimen
    Placebo IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
    analyzed count
    221
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02426125-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-opdivo-432072c9
    nct id
    NCT02426125
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Ramucirumab + Docetaxel
    regimen
    Ramucirumab (10 mg/kg) IV plus docetaxel IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
    analyzed count
    263
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02426125-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-opdivo-432072c9
    nct id
    NCT02426125
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Placebo + Docetaxel
    regimen
    Placebo IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
    analyzed count
    267
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02426125-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-opdivo-432072c9
    nct id
    NCT02426125
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Ramucirumab + Docetaxel
    regimen
    Ramucirumab (10 mg/kg) IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
    analyzed count
    263
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02426125-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-opdivo-432072c9
    nct id
    NCT02426125
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Placebo + Docetaxel
    regimen
    Placebo IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
    analyzed count
    267
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02426125-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-opdivo-432072c9
    nct id
    NCT02426125
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Ramucirumab + Docetaxel
    regimen
    Ramucirumab (10 mg/kg) IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
    analyzed count
    263
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02426125-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-opdivo-432072c9
    nct id
    NCT02426125
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Placebo + Docetaxel
    regimen
    Placebo IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
    analyzed count
    267
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02426125-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-opdivo-432072c9
    nct id
    NCT02426125
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Ramucirumab + Docetaxel
    regimen
    Ramucirumab (10 mg/kg) IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
    analyzed count
    68
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02426125-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-opdivo-432072c9
    nct id
    NCT02426125
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Placebo + Docetaxel
    regimen
    Placebo IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
    analyzed count
    37
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02426125-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-opdivo-432072c9
    nct id
    NCT02426125
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Ramucirumab + Docetaxel
    regimen
    Ramucirumab (10 mg/kg) IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
    analyzed count
    263
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02426125-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-opdivo-432072c9
    nct id
    NCT02426125
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Placebo + Docetaxel
    regimen
    Placebo IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
    analyzed count
    267
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02426125-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-opdivo-432072c9
    nct id
    NCT02426125
    harm key
    EG000
    source section id
    NCT02426125-ae
    event group key
    EG000
    event group label
    Ramucirumab + Docetaxel
    serious affected
    111
    serious at risk
    258
    other affected
    241
    other at risk
    258
    frequency threshold
    0
    collection period
    Up to 64.7 Months
    event definition
    All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-opdivo-432072c9
    nct id
    NCT02426125
    harm key
    EG001
    source section id
    NCT02426125-ae
    event group key
    EG001
    event group label
    Placebo+Docetaxel
    serious affected
    107
    serious at risk
    265
    other affected
    251
    other at risk
    265
    frequency threshold
    0
    collection period
    Up to 64.7 Months
    event definition
    All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-opdivo-432072c9
    nct id
    NCT02426125
    qol key
    qol-0005
    source section id
    NCT02426125-om-0005
    source outcome index
    5
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Time to Deterioration in Quality of Life (QoL) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status/ QoL Scale
    measure definition
    Time to sustained deterioration was defined as time from randomization to first worsening in QoL with no subsequent non-worsened assessment. Worsening in global health status/QoL was defined as a decrease of ≥10 points on a 100-point scale. If a participant did not report worsening, time to sustained deterioration was censored at date of last non-worsened assessment. Scores for global health status/QoL range from 0 to 100 with; higher scores representing better QoL.
    time frame
    Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher scores representing better
    population note
    All randomized participants. Censored participants: Ramucirumab + Docetaxel = 160, Placebo + Docetaxel = 173.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-opdivo-432072c9
    nct id
    NCT02426125
    qol key
    qol-0006
    source section id
    NCT02426125-om-0006
    source outcome index
    6
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
    measure definition
    The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Participants completed the 5-level (no problem, slight problem, moderate problem, severe problem, and inability or extreme problem), 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire concerning their current health state. A unique EQ-5D health state is defined by combining 1 level from each of the 5 dimensions. Scores range from 0 (death) to 1 (perfect health), but scores \<0 are possible based on the algorithm.
    time frame
    Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    All randomized participants with baseline and 30-day follow-up data.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-opdivo-432072c9
    nct id
    NCT02426125
    qol key
    qol-0007
    source section id
    NCT02426125-om-0007
    source outcome index
    7
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS)
    measure definition
    The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. A unique EQ-5D health state is defined by combining 1 level from each of the 5 dimensions. Participants indicated their current health status by marking on a VAS ranging from 100 (best imaginable health state) to 0 (worst imaginable health state).
    time frame
    Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    All randomized participants with baseline and 30-day follow-up data.
    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