Skip to content
Triangle logo TriangleGet started
← Docetaxel: metastatic Non-small cell lung cancer after prior therapy

NCT01673867 · STUDY IN CONTEXT

Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Metastatic Non-squamous NSCLC

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

Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug. Median and hazard ratio computed using Kaplan-Meier method.

All randomized participants

→

secondary · POSTED

ORR was defined as the percentage of participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). BOR was defined as the best investigator-assessed response designation, recorded between the date of randomization and the date of objectively documented progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or the date of subsequent anti-cancer therapy (excluding on-treatment palliative radiotherapy of non-target bone lesions or Central Nervous System (CNS) lesions), whichever occurred first. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CR+PR, confidence interval based on the Clopper and Pearson method.

All randomized participants

→

secondary · POSTED

Time to Objective Response for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.

All randomized participants who demonstrate partial response (PR) or complete response (CR)

→

secondary · POSTED

DOR was defined as the time from the date of first confirmed response to the date of the first documented tumor progression (per RECIST v1.1), as determined by the investigator, or death due to any cause, whichever occurred first. DOR was evaluated only for confirmed responders (i.e. participants with confirmed CR or PR). CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. Participants who neither progressed nor died were censored on the date of their last evaluable tumor assessment. Median computed using Kaplan-Meier method.

All randomized participants who demonstrate partial response (PR) or complete response (CR)

→

secondary · POSTED

PFS was defined as the time from randomization to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Progression will be assessed every 6 weeks (from the first on-study radiographic assessment) until disease progression is noted. Progressive disease was defined as least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Median computed using the Kaplan-Meier method.

All randomized participants

→

secondary · POSTED

Disease-related symptom improvement rate by Week 12 was defined as the percentage of randomized participants who had a 10 point or greater decrease from baseline in average symptom burden index score at any time between randomization and Week 12. The participant portion of the Lung Cancer Symptom Scale (LCSS) consisted of 6 symptom-specific questions that addressed cough, dyspnea, fatigue, pain, hemoptysis, and anorexia, plus 3 summary items on symptom distress, interference with activity level, and global health-related Quality of Life (QoL). The scores range from 0 to 100, with 0 representing the best possible score and 100 being the worst possible score. The average symptom burden index score at each assessment was defined as the mean of the 6 symptom-specific questions of the LCSS. 95% CIs were computed using Clopper-Pearson Method.

All randomized participants

→

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

Unnamed quality-of-life measure · Percentage of Participants Experiencing Disease-Related Symptom Improvement by Week 12

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-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT01673867
qol key
qol-0005
source section id
NCT01673867-om-0005
source outcome index
5
instrument
Unnamed quality-of-life measure
instrument basis
matched 'health-related quality' in the study's own wording
scale title
Percentage of Participants Experiencing Disease-Related Symptom Improvement by Week 12
measure definition
Disease-related symptom improvement rate by Week 12 was defined as the percentage of randomized participants who had a 10 point or greater decrease from baseline in average symptom burden index score at any time between randomization and Week 12. The participant portion of the Lung Cancer Symptom Scale (LCSS) consisted of 6 symptom-specific questions that addressed cough, dyspnea, fatigue, pain, hemoptysis, and anorexia, plus 3 summary items on symptom distress, interference with activity level, and global health-related Quality of Life (QoL). The scores range from 0 to 100, with 0 representing the best possible score and 100 being the worst possible score. The average symptom burden index score at each assessment was defined as the mean of the 6 symptom-specific questions of the LCSS. 95% CIs were computed using Clopper-Pearson Method.
time frame
Randomization to Week 12
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
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
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT01673867
trial label
Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Metastatic Non-squamous NSCLC
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
5
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01673867
    outcome key
    om-0000
    source section id
    NCT01673867-om-0000
    source outcome index
    0
    endpoint
    Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint
    endpoint definition
    Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug. Median and hazard ratio computed using Kaplan-Meier method.
    time origin
    Randomization until 413 deaths, up to March 2015 (approximately 29 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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01673867
    outcome key
    om-0001
    source section id
    NCT01673867-om-0001
    source outcome index
    1
    endpoint
    Objective Response Rate (ORR)
    endpoint definition
    ORR was defined as the percentage of participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). BOR was defined as the best investigator-assessed response designation, recorded between the date of randomization and the date of objectively documented progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or the date of subsequent anti-cancer therapy (excluding on-treatment palliative radiotherapy of non-target bone lesions or Central Nervous System (CNS) lesions), whichever occurred first. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CR+PR, confidence interval based on the Clopper and Pearson method.
    time origin
    From randomization to date of objectively documented progression (up to approximately 110 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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01673867
    outcome key
    om-0002
    source section id
    NCT01673867-om-0002
    source outcome index
    2
    endpoint
    Time To Objective Response (TTOR)
    endpoint definition
    Time to Objective Response for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.
    time origin
    From randomization to the date of first confirmed response (up to approximately 110 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized participants who demonstrate partial response (PR) or complete response (CR)
    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-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01673867
    outcome key
    om-0003
    source section id
    NCT01673867-om-0003
    source outcome index
    3
    endpoint
    Duration of Objective Response (DOOR)
    endpoint definition
    DOR was defined as the time from the date of first confirmed response to the date of the first documented tumor progression (per RECIST v1.1), as determined by the investigator, or death due to any cause, whichever occurred first. DOR was evaluated only for confirmed responders (i.e. participants with confirmed CR or PR). CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. Participants who neither progressed nor died were censored on the date of their last evaluable tumor assessment. Median computed using Kaplan-Meier method.
    time origin
    From randomization to date of first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 110 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized participants who demonstrate partial response (PR) or complete response (CR)
    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-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01673867
    outcome key
    om-0004
    source section id
    NCT01673867-om-0004
    source outcome index
    4
    endpoint
    Progression-Free Survival (PFS)
    endpoint definition
    PFS was defined as the time from randomization to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Progression will be assessed every 6 weeks (from the first on-study radiographic assessment) until disease progression is noted. Progressive disease was defined as least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Median computed using the Kaplan-Meier method.
    time origin
    From randomization to first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 110 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
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01673867
    outcome key
    om-0005
    source section id
    NCT01673867-om-0005
    source outcome index
    5
    endpoint
    Percentage of Participants Experiencing Disease-Related Symptom Improvement by Week 12
    endpoint definition
    Disease-related symptom improvement rate by Week 12 was defined as the percentage of randomized participants who had a 10 point or greater decrease from baseline in average symptom burden index score at any time between randomization and Week 12. The participant portion of the Lung Cancer Symptom Scale (LCSS) consisted of 6 symptom-specific questions that addressed cough, dyspnea, fatigue, pain, hemoptysis, and anorexia, plus 3 summary items on symptom distress, interference with activity level, and global health-related Quality of Life (QoL). The scores range from 0 to 100, with 0 representing the best possible score and 100 being the worst possible score. The average symptom burden index score at each assessment was defined as the mean of the 6 symptom-specific questions of the LCSS. 95% CIs were computed using Clopper-Pearson Method.
    time origin
    Randomization to Week 12
    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
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01673867
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Nivolumab
    regimen
    Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
    analyzed count
    292
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01673867-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01673867
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Docetaxel
    regimen
    Docetaxel 75mg/m\^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
    analyzed count
    290
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01673867-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01673867
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Nivolumab
    regimen
    Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
    analyzed count
    292
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01673867-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01673867
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Docetaxel
    regimen
    Docetaxel 75mg/m\^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
    analyzed count
    290
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01673867-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01673867
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Nivolumab
    regimen
    Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
    analyzed count
    57
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01673867-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01673867
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Docetaxel
    regimen
    Docetaxel 75mg/m\^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
    analyzed count
    37
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01673867-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01673867
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Nivolumab
    regimen
    Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
    analyzed count
    57
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01673867-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01673867
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Docetaxel
    regimen
    Docetaxel 75mg/m\^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
    analyzed count
    37
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01673867-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01673867
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Nivolumab
    regimen
    Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
    analyzed count
    292
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01673867-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01673867
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Docetaxel
    regimen
    Docetaxel 75mg/m\^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
    analyzed count
    290
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01673867-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01673867
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Nivolumab
    regimen
    Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
    analyzed count
    292
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01673867-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01673867
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Docetaxel
    regimen
    Docetaxel 75mg/m\^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
    analyzed count
    290
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01673867-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01673867
    harm key
    EG000
    source section id
    NCT01673867-ae
    event group key
    EG000
    event group label
    Nivolumab 3 mg/kg
    serious affected
    172
    serious at risk
    287
    other affected
    267
    other at risk
    287
    frequency threshold
    5
    collection period
    Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 110 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 108 months).
    event definition
    All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3 mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3 mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab.
    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-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01673867
    harm key
    EG001
    source section id
    NCT01673867-ae
    event group key
    EG001
    event group label
    Nivolumab 480 mg
    serious affected
    5
    serious at risk
    15
    other affected
    12
    other at risk
    15
    frequency threshold
    5
    collection period
    Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 110 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 108 months).
    event definition
    All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3 mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3 mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab.
    undenominated note
    Source null
    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-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01673867
    harm key
    EG002
    source section id
    NCT01673867-ae
    event group key
    EG002
    event group label
    Docetaxel
    serious affected
    161
    serious at risk
    268
    other affected
    258
    other at risk
    268
    frequency threshold
    5
    collection period
    Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 110 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 108 months).
    event definition
    All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3 mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3 mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab.
    undenominated note
    Source null
    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-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01673867
    harm key
    EG003
    source section id
    NCT01673867-ae
    event group key
    EG003
    event group label
    Extension Phase of Docetaxel Arm: Nivolumab 3 mg/kg
    serious affected
    9
    serious at risk
    17
    other affected
    12
    other at risk
    17
    frequency threshold
    5
    collection period
    Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 110 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 108 months).
    event definition
    All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3 mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3 mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab.
    undenominated note
    Source null
    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-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01673867
    harm key
    EG004
    source section id
    NCT01673867-ae
    event group key
    EG004
    event group label
    Extension Phase of Docetaxel Arm: Nivolumab 480 mg
    serious affected
    1
    serious at risk
    1
    other affected
    1
    other at risk
    1
    frequency threshold
    5
    collection period
    Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 110 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 108 months).
    event definition
    All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3 mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3 mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab.
    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-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01673867
    qol key
    qol-0005
    source section id
    NCT01673867-om-0005
    source outcome index
    5
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'health-related quality' in the study's own wording
    scale title
    Percentage of Participants Experiencing Disease-Related Symptom Improvement by Week 12
    measure definition
    Disease-related symptom improvement rate by Week 12 was defined as the percentage of randomized participants who had a 10 point or greater decrease from baseline in average symptom burden index score at any time between randomization and Week 12. The participant portion of the Lung Cancer Symptom Scale (LCSS) consisted of 6 symptom-specific questions that addressed cough, dyspnea, fatigue, pain, hemoptysis, and anorexia, plus 3 summary items on symptom distress, interference with activity level, and global health-related Quality of Life (QoL). The scores range from 0 to 100, with 0 representing the best possible score and 100 being the worst possible score. The average symptom burden index score at each assessment was defined as the mean of the 6 symptom-specific questions of the LCSS. 95% CIs were computed using Clopper-Pearson Method.
    time frame
    Randomization to Week 12
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    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
setting source links

    Preserved source evidence · Not medical advice