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-paclitaxel-protein-bound-particles-albumin-bound-eb290623
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-paclitaxel-protein-bound-particles-albumin-bound-eb290623
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

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
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

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
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

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
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

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
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