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← OPDIVO: resectable Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration (neoadjuvant) after prior therapy

NCT01828099 · STUDY IN CONTEXT

LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer

Draft scope assessment: unclear. Attached because the study's own record names ALK. 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

PFS is defined as the time from the date of randomization to the date of the first radiologically documented disease progression (as assessed by BIRC per RECIST 1.1) or death due to any cause. A patient who had not progressed or died at the date of the analysis cut-off or had received another anticancer therapy had their PFS censored at the time of the last adequate tumor evaluation before the earlier of the cut-off date or the anticancer therapy date. The distribution of PFS was estimated using the Kaplan-Meier (KM) method.

The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.

→

secondary · POSTED

OS defined as time from date of randomization to date of death due to any cause. If the patient was alive at the date of the analysis cut-off or lost to follow-up, then OS was censored at the last contact date prior to data cut-off date. The distribution of OS was estimated using the KM method.

The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization

→

secondary · POSTED

ORR is defined as the percentage of patients with a best overall response defined as complete response (CR) or or partial response (PR) measured by BIRC per RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.

→

secondary · POSTED

ORR is defined as the percentage of patients with a best overall response defined as complete response (CR) or or partial response (PR) measured by investigator assessment per RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.

→

secondary · POSTED

DOR is defined as the time from date of first documented CR or PR to date of first documented disease progression (measured by BIRC assessment per RECIST 1.1) or death due to any cause. CR: Disappearance of all lesions with lymph nodes measuring \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. If a patient had not had an event, DOR was censored at the date of last adequate tumor assessment. Patients who had never achieved a best overall response of CR or PR were excluded from the analysis. The distribution function of DOR was estimated using the KM method.

The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Patients with confirmed CR or PR by BIRC assessment.

→

secondary · POSTED

DOR is defined as the time from date of first documented CR or PR to date of first documented disease progression (measured by investigator assessment per RECIST 1.1) or death due to any cause. CR: Disappearance of all lesions with lymph nodes measuring \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. If a patient had not had an event, DOR was censored at the date of last adequate tumor assessment. Patients who had never achieved a best overall response of CR or PR were excluded from the analysis. The distribution function of DOR was estimated using the KM method.

The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Patients with confirmed CR or PR by investigator assessment.

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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 Definitive 10 Point Deterioration in the Composite Endpoint of Pain, Cough or Dyspnea in the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ)- Lung Cancer (LC) 13 Questionnaire

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-opdivo-9408611e
nct id
NCT01828099
qol key
qol-0014
source section id
NCT01828099-om-0014
source outcome index
14
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Time to Definitive 10 Point Deterioration in the Composite Endpoint of Pain, Cough or Dyspnea in the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ)- Lung Cancer (LC) 13 Questionnaire
measure definition
The EORTC QLQ-LC13 complemented the QLQ-C30 and measured disease symptoms and treatment-related adverse effects. The lung cancer module incorporated one multi-item scale to assess dyspnea and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All of the domain scores ranged from 0 to 100. A high score indicated a high level of symptoms. Time to definitive symptom deterioration for the composite endpoint was defined as the time from the date of randomization to the earliest date when the patient's score showed a 10 point or higher increase from baseline in any of the symptoms (pain, cough or dyspnea) as per EORTC QLQ-LC13 (with no later change below this threshold i.e., \<10 points was observed or if this increase was observed at the last assessment for the patient) or death due to any cause.
time frame
Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Unnamed quality-of-life measure · Time to Definitive Deterioration in the Composite Endpoint of Pain, Cough or Dyspnea in the Lung Cancer Symptom Scale (LCSS)

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-opdivo-9408611e
nct id
NCT01828099
qol key
qol-0015
source section id
NCT01828099-om-0015
source outcome index
15
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Time to Definitive Deterioration in the Composite Endpoint of Pain, Cough or Dyspnea in the Lung Cancer Symptom Scale (LCSS)
measure definition
The LCSS patient scale used a 24-hour recall period and contained nine items: six measuring major symptoms for lung cancer (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain), and three summary items related to total symptom distress, normal activity status, and overall quality of life. The LCSS used a 100mm visual analog scale (VAS) to measure the intensity of patient responses, with zero corresponding to the lowest rating (best status) and 100 representing the highest rating (worst status). Time to definitive deterioration for the composite endpoint was defined as the time from the date of randomization to the earliest date when the patient's score showed a 10 point or higher increase from baseline in any of the LCSS scores related to pain in the chest, cough, or dyspnea (with no later change below this threshold i.e., \<10 points was observed or if this increase was observed at the last assessment for the patient) or death due to any cause.
time frame
Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Least Squares Mean Scores on the EORTC-QLQ C30

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-opdivo-9408611e
nct id
NCT01828099
qol key
qol-0016
source section id
NCT01828099-om-0016
source outcome index
16
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Least Squares Mean Scores on the EORTC-QLQ C30
measure definition
The EORTC QLQ-C30 contained 30 items and was of both multi-item scales and single-item measures, including 5 functional scales (physical, role, emotional, cognitive, and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health status (GHS)/quality of life (QoL) scale. Items were assessed on a 4- or 7-level Likert scale, ranging from 1="very poor" to 7= "excellent" for GHS items and 1= "not at all" to 4= "very much" for all other items. The scores of the scales were averaged from the scores of the component items, transformed, and analyzed on a 0 - 100 scale. A high score represented a higher response level. The scores were analyzed using repeated measurement model for longitudinal data, including terms for visit, treatment, treatment by time interaction, strata and baseline score. Overall mean and standard error were obtained
time frame
Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Participants with a baseline assessment for at least one of the scales/single items
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Least Squares Mean Scores on the EORTC QLQ- LC13

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-opdivo-9408611e
nct id
NCT01828099
qol key
qol-0017
source section id
NCT01828099-om-0017
source outcome index
17
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Least Squares Mean Scores on the EORTC QLQ- LC13
measure definition
The EORTC QLQ-LC13 was used in conjunction with the EORTC QLQ-C30 and provided information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporated one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. Items were scored on a 4-point Likert scale ranging from 1="not at all" to 4="very much". For the multi-item scale, the scores were averaged from the scores of the component items, transformed, and then analyzed on a 0 - 100 scale. For the single item scale, raw scores were transformed and analyzed on a 0-100 scale. A high score indicated a high level of symptoms The scores were analyzed using repeated measurement model for longitudinal data, including terms for visit, treatment, treatment by time interaction, strata and baseline score. Overall mean and standard error were obtained.
time frame
Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Participants with a baseline assessment for at least one of the domain scores
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Patient-reported symptom or function measure · Least Squares Mean Scores on the Lung Cancer Symptom Scale (LCSS)

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

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-opdivo-9408611e
nct id
NCT01828099
qol key
qol-0018
source section id
NCT01828099-om-0018
source outcome index
18
instrument
Patient-reported symptom or function measure
instrument basis
matched 'symptom burden' in the study's own wording
scale title
Least Squares Mean Scores on the Lung Cancer Symptom Scale (LCSS)
measure definition
The LCSS consisted of 9 individual items; 6 measured lung cancer symptoms (appetite, fatigue, cough, dyspnea, hemoptysis, and pain); the remaining 3 items measured general lung cancer symptom distress, interference with daily activities and overall QoL. Each item was scored on a 100-millimeter Visual Analogue Scale (VAS), with scores ranging from 0 to 100 (0 = best outcome). Total score was calculated as the average of the aggregate score of all 9 items. Scores ranged from 0 to 100, with higher total scores indicating a greater overall impact of symptoms on the patient's QoL. The Symptom Burden Index (SBI) was calculated as the average of the six symptom items. It also ranged from 0 to 100, with higher scores indicating greater symptom burden. Scores were analyzed using repeated measurement model for longitudinal data, including terms for visit, treatment, treatment by time interaction, strata and baseline score. Overall mean and standard error were obtained.
time frame
Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months
analysis role
secondary
reporting status
POSTED
higher is better
0
direction quote
higher scores indicating greater symptom
population note
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Participants with a baseline assessment for at least one of the domain scores
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Least Squares Mean Scores on the EQ-5D-5L Index

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-opdivo-9408611e
nct id
NCT01828099
qol key
qol-0019
source section id
NCT01828099-om-0019
source outcome index
19
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Least Squares Mean Scores on the EQ-5D-5L Index
measure definition
The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each of these dimensions, the participant self-assigned a score: from 1 (no problems) to 5 (extreme problems). The 5 digit health states obtained for each dimension was converted into a single mean index value based on the EQ-5D crosswalk value set for the UK using the time trade-off method. This index ranges from -0.594 (worst health) to 1.0 (best health). The scores were analyzed using repeated measurement model for longitudinal data, including terms for visit, treatment, treatment by time interaction, strata and baseline score. Overall mean and standard error were obtained.
time frame
Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Participants with a baseline assessment.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Least Squares Mean Scores on the EQ-5D-5L Visual Analogue Score (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-non-small-cell-lung-cancer-opdivo-9408611e
nct id
NCT01828099
qol key
qol-0020
source section id
NCT01828099-om-0020
source outcome index
20
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Least Squares Mean Scores on the EQ-5D-5L Visual Analogue Score (VAS)
measure definition
The EQ-5D-5L questionnaire is a standardized measure of health status. The EQ-5D-5L descriptive system comprises of the 5 following dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Along with the five dimensions of health, the EQ-5D-5L includes a VAS where respondents rate their overall health status on a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state. A positive change from baseline indicates improvement. The scores were analyzed using repeated measurement model for longitudinal data, including terms for visit, treatment, treatment by time interaction, strata and baseline score. Overall mean and standard error were obtained.
time frame
Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Participants with a baseline assessment.
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-opdivo-9408611e
nct id
NCT01828099
trial label
LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer
applicability
unclear
applicability note
Attached because the study's own record names ALK. 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
6
qol Count
7
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01828099
    outcome key
    om-0000
    source section id
    NCT01828099-om-0000
    source outcome index
    0
    endpoint
    Progression Free Survival (PFS) by Blinded Independent Review Committee (BIRC)
    endpoint definition
    PFS is defined as the time from the date of randomization to the date of the first radiologically documented disease progression (as assessed by BIRC per RECIST 1.1) or death due to any cause. A patient who had not progressed or died at the date of the analysis cut-off or had received another anticancer therapy had their PFS censored at the time of the last adequate tumor evaluation before the earlier of the cut-off date or the anticancer therapy date. The distribution of PFS was estimated using the Kaplan-Meier (KM) method.
    time origin
    From the date of randomization to the date of first radiologically documented disease progression or death due to any cause, up to approximately 34 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
    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-opdivo-9408611e
    nct id
    NCT01828099
    outcome key
    om-0001
    source section id
    NCT01828099-om-0001
    source outcome index
    1
    endpoint
    Overall Survival (OS)
    endpoint definition
    OS defined as time from date of randomization to date of death due to any cause. If the patient was alive at the date of the analysis cut-off or lost to follow-up, then OS was censored at the last contact date prior to data cut-off date. The distribution of OS was estimated using the KM method.
    time origin
    From date of randomization to date of death due to any cause, up to approximately 120 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization
    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-opdivo-9408611e
    nct id
    NCT01828099
    outcome key
    om-0002
    source section id
    NCT01828099-om-0002
    source outcome index
    2
    endpoint
    Overall Response Rate (ORR) by BIRC Assessment
    endpoint definition
    ORR is defined as the percentage of patients with a best overall response defined as complete response (CR) or or partial response (PR) measured by BIRC per RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
    time origin
    Up to approximately 34 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
    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-opdivo-9408611e
    nct id
    NCT01828099
    outcome key
    om-0003
    source section id
    NCT01828099-om-0003
    source outcome index
    3
    endpoint
    Overall Response Rate (ORR) by Investigator Assessment
    endpoint definition
    ORR is defined as the percentage of patients with a best overall response defined as complete response (CR) or or partial response (PR) measured by investigator assessment per RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
    time origin
    Up to approximately 120 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
    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-opdivo-9408611e
    nct id
    NCT01828099
    outcome key
    om-0004
    source section id
    NCT01828099-om-0004
    source outcome index
    4
    endpoint
    Duration of Response (DOR) by BIRC Assessment
    endpoint definition
    DOR is defined as the time from date of first documented CR or PR to date of first documented disease progression (measured by BIRC assessment per RECIST 1.1) or death due to any cause. CR: Disappearance of all lesions with lymph nodes measuring \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. If a patient had not had an event, DOR was censored at the date of last adequate tumor assessment. Patients who had never achieved a best overall response of CR or PR were excluded from the analysis. The distribution function of DOR was estimated using the KM method.
    time origin
    From first documented response to first documented disease progression or death, assessed up to approximately 34 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Patients with confirmed CR or PR by BIRC assessment.
    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-opdivo-9408611e
    nct id
    NCT01828099
    outcome key
    om-0005
    source section id
    NCT01828099-om-0005
    source outcome index
    5
    endpoint
    Duration of Response (DOR) by Investigator Assessment
    endpoint definition
    DOR is defined as the time from date of first documented CR or PR to date of first documented disease progression (measured by investigator assessment per RECIST 1.1) or death due to any cause. CR: Disappearance of all lesions with lymph nodes measuring \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. If a patient had not had an event, DOR was censored at the date of last adequate tumor assessment. Patients who had never achieved a best overall response of CR or PR were excluded from the analysis. The distribution function of DOR was estimated using the KM method.
    time origin
    From first documented response to first documented disease progression or death, assessed up to approximately 120 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Patients with confirmed CR or PR by investigator assessment.
    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-opdivo-9408611e
    nct id
    NCT01828099
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Ceritinib
    regimen
    Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state
    analyzed count
    189
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01828099-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01828099
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Chemotherapy
    regimen
    Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance)
    analyzed count
    187
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01828099-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01828099
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Ceritinib
    regimen
    Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state
    analyzed count
    189
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01828099-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01828099
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Chemotherapy
    regimen
    Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance)
    analyzed count
    187
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01828099-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01828099
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Ceritinib
    regimen
    Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state
    analyzed count
    189
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01828099-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01828099
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Chemotherapy
    regimen
    Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance)
    analyzed count
    187
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01828099-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01828099
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Ceritinib
    regimen
    Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state
    analyzed count
    189
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01828099-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01828099
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Chemotherapy
    regimen
    Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance)
    analyzed count
    187
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01828099-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01828099
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Ceritinib
    regimen
    Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state
    analyzed count
    137
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01828099-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01828099
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Chemotherapy
    regimen
    Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance)
    analyzed count
    50
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01828099-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01828099
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Ceritinib
    regimen
    Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state
    analyzed count
    139
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01828099-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01828099
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Chemotherapy
    regimen
    Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance)
    analyzed count
    62
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01828099-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01828099
    harm key
    EG000
    source section id
    NCT01828099-ae
    event group key
    EG000
    event group label
    Ceritinib
    serious affected
    93
    serious at risk
    189
    other affected
    186
    other at risk
    189
    frequency threshold
    5
    collection period
    All-cause mortality: from randomization up to approx. 120 months, including post-treatment survival follow-up period. Serious and Other Adverse Events (AEs): from first dose of study treatment until 30 days after last dose (or start of crossover treatment), up to approx. 120 months. For participants who crossed over, AEs were also collected from start of crossover treatment to 30 days post-crossover treatment (extension-treatment period), up to approx. 108 months.
    event definition
    All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
    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-opdivo-9408611e
    nct id
    NCT01828099
    harm key
    EG001
    source section id
    NCT01828099-ae
    event group key
    EG001
    event group label
    Chemotherapy
    serious affected
    64
    serious at risk
    175
    other affected
    166
    other at risk
    175
    frequency threshold
    5
    collection period
    All-cause mortality: from randomization up to approx. 120 months, including post-treatment survival follow-up period. Serious and Other Adverse Events (AEs): from first dose of study treatment until 30 days after last dose (or start of crossover treatment), up to approx. 120 months. For participants who crossed over, AEs were also collected from start of crossover treatment to 30 days post-crossover treatment (extension-treatment period), up to approx. 108 months.
    event definition
    All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
    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-opdivo-9408611e
    nct id
    NCT01828099
    harm key
    EG002
    source section id
    NCT01828099-ae
    event group key
    EG002
    event group label
    Chemotherapy to Ceritinib (Extension-treatment)
    serious affected
    47
    serious at risk
    100
    other affected
    99
    other at risk
    100
    frequency threshold
    5
    collection period
    All-cause mortality: from randomization up to approx. 120 months, including post-treatment survival follow-up period. Serious and Other Adverse Events (AEs): from first dose of study treatment until 30 days after last dose (or start of crossover treatment), up to approx. 120 months. For participants who crossed over, AEs were also collected from start of crossover treatment to 30 days post-crossover treatment (extension-treatment period), up to approx. 108 months.
    event definition
    All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
    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-opdivo-9408611e
    nct id
    NCT01828099
    harm key
    EG003
    source section id
    NCT01828099-ae
    event group key
    EG003
    event group label
    Ceritinib (Post-treatment Follow-up)
    serious affected
    0
    serious at risk
    0
    other affected
    0
    other at risk
    0
    frequency threshold
    5
    collection period
    All-cause mortality: from randomization up to approx. 120 months, including post-treatment survival follow-up period. Serious and Other Adverse Events (AEs): from first dose of study treatment until 30 days after last dose (or start of crossover treatment), up to approx. 120 months. For participants who crossed over, AEs were also collected from start of crossover treatment to 30 days post-crossover treatment (extension-treatment period), up to approx. 108 months.
    event definition
    All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
    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-opdivo-9408611e
    nct id
    NCT01828099
    harm key
    EG004
    source section id
    NCT01828099-ae
    event group key
    EG004
    event group label
    Chemotherapy (Post-treatment Follow-up)
    serious affected
    0
    serious at risk
    0
    other affected
    0
    other at risk
    0
    frequency threshold
    5
    collection period
    All-cause mortality: from randomization up to approx. 120 months, including post-treatment survival follow-up period. Serious and Other Adverse Events (AEs): from first dose of study treatment until 30 days after last dose (or start of crossover treatment), up to approx. 120 months. For participants who crossed over, AEs were also collected from start of crossover treatment to 30 days post-crossover treatment (extension-treatment period), up to approx. 108 months.
    event definition
    All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
    undenominated note
    Source null
    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-opdivo-9408611e
    nct id
    NCT01828099
    harm key
    EG005
    source section id
    NCT01828099-ae
    event group key
    EG005
    event group label
    Chemotherapy to Ceritinib (Post-treatment Follow-up)
    serious affected
    0
    serious at risk
    0
    other affected
    0
    other at risk
    0
    frequency threshold
    5
    collection period
    All-cause mortality: from randomization up to approx. 120 months, including post-treatment survival follow-up period. Serious and Other Adverse Events (AEs): from first dose of study treatment until 30 days after last dose (or start of crossover treatment), up to approx. 120 months. For participants who crossed over, AEs were also collected from start of crossover treatment to 30 days post-crossover treatment (extension-treatment period), up to approx. 108 months.
    event definition
    All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
    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-opdivo-9408611e
    nct id
    NCT01828099
    qol key
    qol-0014
    source section id
    NCT01828099-om-0014
    source outcome index
    14
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Time to Definitive 10 Point Deterioration in the Composite Endpoint of Pain, Cough or Dyspnea in the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ)- Lung Cancer (LC) 13 Questionnaire
    measure definition
    The EORTC QLQ-LC13 complemented the QLQ-C30 and measured disease symptoms and treatment-related adverse effects. The lung cancer module incorporated one multi-item scale to assess dyspnea and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All of the domain scores ranged from 0 to 100. A high score indicated a high level of symptoms. Time to definitive symptom deterioration for the composite endpoint was defined as the time from the date of randomization to the earliest date when the patient's score showed a 10 point or higher increase from baseline in any of the symptoms (pain, cough or dyspnea) as per EORTC QLQ-LC13 (with no later change below this threshold i.e., \<10 points was observed or if this increase was observed at the last assessment for the patient) or death due to any cause.
    time frame
    Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
    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-opdivo-9408611e
    nct id
    NCT01828099
    qol key
    qol-0015
    source section id
    NCT01828099-om-0015
    source outcome index
    15
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Time to Definitive Deterioration in the Composite Endpoint of Pain, Cough or Dyspnea in the Lung Cancer Symptom Scale (LCSS)
    measure definition
    The LCSS patient scale used a 24-hour recall period and contained nine items: six measuring major symptoms for lung cancer (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain), and three summary items related to total symptom distress, normal activity status, and overall quality of life. The LCSS used a 100mm visual analog scale (VAS) to measure the intensity of patient responses, with zero corresponding to the lowest rating (best status) and 100 representing the highest rating (worst status). Time to definitive deterioration for the composite endpoint was defined as the time from the date of randomization to the earliest date when the patient's score showed a 10 point or higher increase from baseline in any of the LCSS scores related to pain in the chest, cough, or dyspnea (with no later change below this threshold i.e., \<10 points was observed or if this increase was observed at the last assessment for the patient) or death due to any cause.
    time frame
    Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
    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-opdivo-9408611e
    nct id
    NCT01828099
    qol key
    qol-0016
    source section id
    NCT01828099-om-0016
    source outcome index
    16
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Least Squares Mean Scores on the EORTC-QLQ C30
    measure definition
    The EORTC QLQ-C30 contained 30 items and was of both multi-item scales and single-item measures, including 5 functional scales (physical, role, emotional, cognitive, and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health status (GHS)/quality of life (QoL) scale. Items were assessed on a 4- or 7-level Likert scale, ranging from 1="very poor" to 7= "excellent" for GHS items and 1= "not at all" to 4= "very much" for all other items. The scores of the scales were averaged from the scores of the component items, transformed, and analyzed on a 0 - 100 scale. A high score represented a higher response level. The scores were analyzed using repeated measurement model for longitudinal data, including terms for visit, treatment, treatment by time interaction, strata and baseline score. Overall mean and standard error were obtained
    time frame
    Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Participants with a baseline assessment for at least one of the scales/single items
    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-opdivo-9408611e
    nct id
    NCT01828099
    qol key
    qol-0017
    source section id
    NCT01828099-om-0017
    source outcome index
    17
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Least Squares Mean Scores on the EORTC QLQ- LC13
    measure definition
    The EORTC QLQ-LC13 was used in conjunction with the EORTC QLQ-C30 and provided information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporated one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. Items were scored on a 4-point Likert scale ranging from 1="not at all" to 4="very much". For the multi-item scale, the scores were averaged from the scores of the component items, transformed, and then analyzed on a 0 - 100 scale. For the single item scale, raw scores were transformed and analyzed on a 0-100 scale. A high score indicated a high level of symptoms The scores were analyzed using repeated measurement model for longitudinal data, including terms for visit, treatment, treatment by time interaction, strata and baseline score. Overall mean and standard error were obtained.
    time frame
    Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Participants with a baseline assessment for at least one of the domain scores
    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-opdivo-9408611e
    nct id
    NCT01828099
    qol key
    qol-0018
    source section id
    NCT01828099-om-0018
    source outcome index
    18
    instrument
    Patient-reported symptom or function measure
    instrument basis
    matched 'symptom burden' in the study's own wording
    scale title
    Least Squares Mean Scores on the Lung Cancer Symptom Scale (LCSS)
    measure definition
    The LCSS consisted of 9 individual items; 6 measured lung cancer symptoms (appetite, fatigue, cough, dyspnea, hemoptysis, and pain); the remaining 3 items measured general lung cancer symptom distress, interference with daily activities and overall QoL. Each item was scored on a 100-millimeter Visual Analogue Scale (VAS), with scores ranging from 0 to 100 (0 = best outcome). Total score was calculated as the average of the aggregate score of all 9 items. Scores ranged from 0 to 100, with higher total scores indicating a greater overall impact of symptoms on the patient's QoL. The Symptom Burden Index (SBI) was calculated as the average of the six symptom items. It also ranged from 0 to 100, with higher scores indicating greater symptom burden. Scores were analyzed using repeated measurement model for longitudinal data, including terms for visit, treatment, treatment by time interaction, strata and baseline score. Overall mean and standard error were obtained.
    time frame
    Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    0
    direction quote
    higher scores indicating greater symptom
    population note
    The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Participants with a baseline assessment for at least one of the domain scores
    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-opdivo-9408611e
    nct id
    NCT01828099
    qol key
    qol-0019
    source section id
    NCT01828099-om-0019
    source outcome index
    19
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Least Squares Mean Scores on the EQ-5D-5L Index
    measure definition
    The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each of these dimensions, the participant self-assigned a score: from 1 (no problems) to 5 (extreme problems). The 5 digit health states obtained for each dimension was converted into a single mean index value based on the EQ-5D crosswalk value set for the UK using the time trade-off method. This index ranges from -0.594 (worst health) to 1.0 (best health). The scores were analyzed using repeated measurement model for longitudinal data, including terms for visit, treatment, treatment by time interaction, strata and baseline score. Overall mean and standard error were obtained.
    time frame
    Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Participants with a baseline assessment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01828099
    qol key
    qol-0020
    source section id
    NCT01828099-om-0020
    source outcome index
    20
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Least Squares Mean Scores on the EQ-5D-5L Visual Analogue Score (VAS)
    measure definition
    The EQ-5D-5L questionnaire is a standardized measure of health status. The EQ-5D-5L descriptive system comprises of the 5 following dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Along with the five dimensions of health, the EQ-5D-5L includes a VAS where respondents rate their overall health status on a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state. A positive change from baseline indicates improvement. The scores were analyzed using repeated measurement model for longitudinal data, including terms for visit, treatment, treatment by time interaction, strata and baseline score. Overall mean and standard error were obtained.
    time frame
    Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
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    direction quote
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    population note
    The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Participants with a baseline assessment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
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    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice