Trial Outcomes & Findings for A Study of Atezolizumab Compared With a Single-Agent Chemotherapy in Treatment Naïve Participants With Locally Advanced or Recurrent or Metastatic Non-Small Cell Lung Cancer Who Are Deemed Unsuitable For Platinum-Doublet Chemotherapy (NCT NCT03191786)
NCT ID: NCT03191786
Last Updated: 2024-10-23
Results Overview
OS was defined as the time between the date of randomization and the date of death due to any cause. Kaplan-Meier (KM) estimates were used to calculate median.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
453 participants
Primary outcome timeframe
From randomization up to death from any cause (up to approximately 55 months)
Results posted on
2024-10-23
Participant Flow
Participants diagnosed with advanced or recurrent (stage IIIb) or metastatic (stage IV) non-small cell lung cancer (NSCLC) took part in the study across 85 investigative sites in 23 countries from 11 Sep 2017 to 25 Oct 2023.
A total of 453 participants were randomized in 2:1 ratio to atezolizumab arm and single agent chemotherapy arm(vinorelbine or gemcitabine) in this study. 447 participants received at least one dose of study treatment.
Participant milestones
| Measure |
Atezolizumab
Participants received atezolizumab 1200 milligrams (mg), as intravenous (IV) infusion on Day 1 of each 21-day cycle until loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death.
|
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)
Participants received single agent chemotherapy; either vinorelbine oral or IV, or gemcitabine IV, according to the label based on investigator's choice until disease progression unacceptable toxicity, participant or physician decision to discontinue, or death.
|
|---|---|---|
|
Overall Study
STARTED
|
302
|
151
|
|
Overall Study
Safety Evaluable Population
|
300
|
147
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
302
|
151
|
Reasons for withdrawal
| Measure |
Atezolizumab
Participants received atezolizumab 1200 milligrams (mg), as intravenous (IV) infusion on Day 1 of each 21-day cycle until loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death.
|
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)
Participants received single agent chemotherapy; either vinorelbine oral or IV, or gemcitabine IV, according to the label based on investigator's choice until disease progression unacceptable toxicity, participant or physician decision to discontinue, or death.
|
|---|---|---|
|
Overall Study
Death
|
236
|
127
|
|
Overall Study
Lost to Follow-up
|
9
|
3
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Moved to Post Trial Access Program
|
30
|
5
|
|
Overall Study
Withdrawal by Subject
|
26
|
16
|
Baseline Characteristics
A Study of Atezolizumab Compared With a Single-Agent Chemotherapy in Treatment Naïve Participants With Locally Advanced or Recurrent or Metastatic Non-Small Cell Lung Cancer Who Are Deemed Unsuitable For Platinum-Doublet Chemotherapy
Baseline characteristics by cohort
| Measure |
Atezolizumab
n=302 Participants
Participants received atezolizumab 1200 mg, as IV infusion on Day 1 of each 21-day cycle until loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death.
|
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)
n=151 Participants
Participants received single agent chemotherapy; either vinorelbine oral or IV, or gemcitabine IV, according to the label based on investigator's choice until disease progression unacceptable toxicity, participant or physician decision to discontinue, or death.
|
Total
n=453 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.6 Years
STANDARD_DEVIATION 9.1 • n=93 Participants
|
73.8 Years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
73.7 Years
STANDARD_DEVIATION 8.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
125 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
220 Participants
n=93 Participants
|
108 Participants
n=4 Participants
|
328 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
47 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
69 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
242 Participants
n=93 Participants
|
126 Participants
n=4 Participants
|
368 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
12 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
75 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
113 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
203 Participants
n=93 Participants
|
95 Participants
n=4 Participants
|
298 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: From randomization up to death from any cause (up to approximately 55 months)Population: ITT population included all randomized participants irrespective of whether the assigned treatment was actually received.
OS was defined as the time between the date of randomization and the date of death due to any cause. Kaplan-Meier (KM) estimates were used to calculate median.
Outcome measures
| Measure |
Atezolizumab
n=302 Participants
Participants received atezolizumab 1200 mg, as IV infusion on Day 1 of each 21-day cycle until loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death.
|
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)
n=151 Participants
Participants received single agent chemotherapy; either vinorelbine oral or IV, or gemcitabine IV, according to the label based on investigator's choice until disease progression unacceptable toxicity, participant or physician decision to discontinue, or death.
|
|---|---|---|
|
Overall Survival (OS)
|
10.3 Months
Interval 9.4 to 11.9
|
9.2 Months
Interval 5.9 to 11.2
|
SECONDARY outcome
Timeframe: 6, 12, 18 and 24 monthsPopulation: ITT population included all randomized participants irrespective of whether the assigned treatment was actually received.
OS was defined as the time between the date of randomization and the date of death due to any cause. OS rate at 6, 12, 18 and 24 months were estimated for each treatment arm using Kaplan Meier methodology. Percentages were rounded off to the nearest decimal point.
Outcome measures
| Measure |
Atezolizumab
n=302 Participants
Participants received atezolizumab 1200 mg, as IV infusion on Day 1 of each 21-day cycle until loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death.
|
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)
n=151 Participants
Participants received single agent chemotherapy; either vinorelbine oral or IV, or gemcitabine IV, according to the label based on investigator's choice until disease progression unacceptable toxicity, participant or physician decision to discontinue, or death.
|
|---|---|---|
|
OS Rates at the 6, 12, 18, 24-Months Timepoints
6 Months
|
64.0 Percentage of participants
Interval 58.6 to 69.5
|
57.5 Percentage of participants
Interval 49.4 to 65.7
|
|
OS Rates at the 6, 12, 18, 24-Months Timepoints
12 Months
|
43.7 Percentage of participants
Interval 37.9 to 49.4
|
38.6 Percentage of participants
Interval 30.5 to 46.7
|
|
OS Rates at the 6, 12, 18, 24-Months Timepoints
18 Months
|
31.4 Percentage of participants
Interval 26.0 to 36.8
|
24.0 Percentage of participants
Interval 16.8 to 31.2
|
|
OS Rates at the 6, 12, 18, 24-Months Timepoints
24 Months
|
24.3 Percentage of participants
Interval 19.3 to 29.4
|
12.4 Percentage of participants
Interval 6.7 to 18.0
|
SECONDARY outcome
Timeframe: From randomization to the first occurence of disease progression or death from any cause, whichever occurs first (up to approximately 55 months)Population: ITT population included all randomized participants irrespective of whether the assigned treatment was actually received.
Objective response rate (ORR)=best overall response (BOR) of either complete response (CR)/partial response (PR), as determined by investigator with use of RECIST v1.1. CR= disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \<10 millimeters (mm). PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. A minimum interval of 6 weeks (42 days) was considered for stable disease (SD) to be assigned as BOR, i.e. in case the single response is SD, PR or CR, this single response must have been assessed no less than 6 weeks (at least 42 days) after start date of study treatment. SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the diameters while in the study. Percentages were rounded off to the nearest decimal point.
Outcome measures
| Measure |
Atezolizumab
n=302 Participants
Participants received atezolizumab 1200 mg, as IV infusion on Day 1 of each 21-day cycle until loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death.
|
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)
n=151 Participants
Participants received single agent chemotherapy; either vinorelbine oral or IV, or gemcitabine IV, according to the label based on investigator's choice until disease progression unacceptable toxicity, participant or physician decision to discontinue, or death.
|
|---|---|---|
|
Percentage of Participants With Objective Response, as Determined by the Investigator Using Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1)
|
16.9 Percentage of participants
Interval 12.8 to 21.6
|
7.9 Percentage of participants
Interval 4.2 to 13.5
|
SECONDARY outcome
Timeframe: From randomization to the first occurence of disease progression or death from any cause, whichever occurs first (up to approximately 55 months)Population: ITT population included all randomized participants irrespective of whether the assigned treatment was actually received.
PFS was defined as the time from randomization to the first documented disease progression as determined by the investigator with the use of RECIST v1.1 or death from any cause, whichever occurs first. Progressive disease (PD) was defined as at least 20% increase in the sum of diameters of lesions, taking as reference the smallest sum during the study (nadir), including baseline. KM estimates were used to calculate median.
Outcome measures
| Measure |
Atezolizumab
n=302 Participants
Participants received atezolizumab 1200 mg, as IV infusion on Day 1 of each 21-day cycle until loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death.
|
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)
n=151 Participants
Participants received single agent chemotherapy; either vinorelbine oral or IV, or gemcitabine IV, according to the label based on investigator's choice until disease progression unacceptable toxicity, participant or physician decision to discontinue, or death.
|
|---|---|---|
|
Progression-Free Survival (PFS), as Determined by the Investigator Using RECIST v1.1
|
4.2 Months
Interval 3.7 to 5.5
|
4.0 Months
Interval 2.9 to 5.4
|
SECONDARY outcome
Timeframe: Time from the first occurrence of a documented objective response to the time of disease progression or death from any cause, whichever occurs first (up to approximately 55 months)Population: ITT population included all randomized participants irrespective of whether the assigned treatment was actually received. Overall number analyzed is the number of participants with objective response (i.e. responders).
DOR was defined as the time from the first tumor assessment that supports the participants' objective response (CR or PR, whichever is first reported) to documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first, among participants who have a best overall response as CR or PR. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD was defined as at least 20% increase in the sum of diameters of lesions, taking as reference the smallest sum during the study (nadir), including baseline. KM estimates were used to calculate median.
Outcome measures
| Measure |
Atezolizumab
n=51 Participants
Participants received atezolizumab 1200 mg, as IV infusion on Day 1 of each 21-day cycle until loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death.
|
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)
n=12 Participants
Participants received single agent chemotherapy; either vinorelbine oral or IV, or gemcitabine IV, according to the label based on investigator's choice until disease progression unacceptable toxicity, participant or physician decision to discontinue, or death.
|
|---|---|---|
|
Duration of Response (DOR), as Determined by the Investigator Using RECIST v1.1
|
14.0 Months
Interval 8.1 to 20.3
|
7.8 Months
Interval 4.8 to 9.7
|
SECONDARY outcome
Timeframe: Baseline up to 90 days after last dose of atezolizumab (approximately 62 months)Population: Safety-evaluable population included all randomized participants who received any amount of study treatment.
An AE was any untoward medical occurrence in participant administered a pharmaceutical product \& regardless of causal relationship with this treatment. An AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. AEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 4.0 (NCI-CTCAE, v4.0).
Outcome measures
| Measure |
Atezolizumab
n=300 Participants
Participants received atezolizumab 1200 mg, as IV infusion on Day 1 of each 21-day cycle until loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death.
|
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)
n=147 Participants
Participants received single agent chemotherapy; either vinorelbine oral or IV, or gemcitabine IV, according to the label based on investigator's choice until disease progression unacceptable toxicity, participant or physician decision to discontinue, or death.
|
|---|---|---|
|
Percentage of Participants With At Least One Adverse Event (AE)
|
91.7 Percentage of participants
|
97.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of each treatment cycle up to 30 days after last dose (up to approximately 55 months) (Cycle length = 21 days)Population: ITT population included all randomized participants irrespective of whether the assigned treatment was actually received. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
EORTC QLQ-C30 consists of 30 questions that assess 5 aspects of patient functioning (physical, emotional, role, cognitive, and social), 3 symptom scales (fatigue, nausea and vomiting, pain), global health/quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). It was scored according to EORTC scoring manual (Fayers et al. 2001). All EORTC scales \& single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high/healthy level of functioning/HRQoL (Health-Related Quality of Life); however a high score for a symptom scale represents a high level of symptomatology or problems. A ≥10-point change in the symptoms subscale score was perceived by participants as clinically significant (Osoba et al. 1998). A positive change from baseline=improvement \& negative change from baseline indicated worsening.
Outcome measures
| Measure |
Atezolizumab
n=302 Participants
Participants received atezolizumab 1200 mg, as IV infusion on Day 1 of each 21-day cycle until loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death.
|
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)
n=151 Participants
Participants received single agent chemotherapy; either vinorelbine oral or IV, or gemcitabine IV, according to the label based on investigator's choice until disease progression unacceptable toxicity, participant or physician decision to discontinue, or death.
|
|---|---|---|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
GHS/HRQoL Scale Score, Baseline
|
54.70 units of a scale
Standard Deviation 22.00
|
55.25 units of a scale
Standard Deviation 21.06
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
GHS/HRQoL Scale Score, Week 6
|
2.09 units of a scale
Standard Deviation 24.11
|
0.29 units of a scale
Standard Deviation 22.94
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
GHS/HRQoL Scale Score, Week 12
|
2.76 units of a scale
Standard Deviation 23.42
|
1.85 units of a scale
Standard Deviation 19.94
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
GHS/HRQoL Scale Score, Week 18
|
4.20 units of a scale
Standard Deviation 24.27
|
-0.42 units of a scale
Standard Deviation 19.52
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
GHS/HRQoL Scale Score, Week 24
|
4.92 units of a scale
Standard Deviation 23.90
|
-1.72 units of a scale
Standard Deviation 18.82
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
GHS/HRQoL Scale Score, Week 30
|
4.32 units of a scale
Standard Deviation 21.12
|
2.65 units of a scale
Standard Deviation 13.70
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
GHS/HRQoL Scale Score, Week 36
|
8.20 units of a scale
Standard Deviation 23.55
|
-0.52 units of a scale
Standard Deviation 22.25
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
GHS/HRQoL Scale Score, Week 42
|
6.17 units of a scale
Standard Deviation 24.98
|
1.19 units of a scale
Standard Deviation 19.02
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
GHS/HRQoL Scale Score, Week 48
|
6.44 units of a scale
Standard Deviation 27.37
|
4.86 units of a scale
Standard Deviation 15.67
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
GHS/HRQoL Scale Score, Week 57
|
8.56 units of a scale
Standard Deviation 20.46
|
8.33 units of a scale
Standard Deviation 12.60
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
GHS/HRQoL Scale Score, Week 66
|
6.82 units of a scale
Standard Deviation 19.15
|
5.00 units of a scale
Standard Deviation 17.28
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
GHS/HRQoL Scale Score, Week 75
|
3.85 units of a scale
Standard Deviation 21.11
|
2.08 units of a scale
Standard Deviation 24.88
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
GHS/HRQoL Scale Score, Week 84
|
11.40 units of a scale
Standard Deviation 20.07
|
-2.78 units of a scale
Standard Deviation 12.73
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
GHS/HRQoL Scale Score, Week 93
|
2.08 units of a scale
Standard Deviation 24.61
|
-12.50 units of a scale
Standard Deviation 5.89
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Emotional Functioning, Week 24
|
4.13 units of a scale
Standard Deviation 17.07
|
4.07 units of a scale
Standard Deviation 17.40
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
GHS/HRQoL Scale Score, Week 102
|
4.69 units of a scale
Standard Deviation 18.50
|
-25.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
GHS/HRQoL Scale Score, Week 120
|
2.38 units of a scale
Standard Deviation 20.52
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
GHS/HRQoL Scale Score, Week 138
|
1.19 units of a scale
Standard Deviation 25.91
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
GHS/HRQoL Scale Score, Week 156
|
-2.38 units of a scale
Standard Deviation 17.82
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
GHS/HRQoL Scale Score, Week 183
|
-6.67 units of a scale
Standard Deviation 19.00
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
GHS/HRQoL Scale Score, Week 192
|
-4.17 units of a scale
Standard Deviation 20.97
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
GHS/HRQoL Scale Score, Week 201
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
GHS/HRQoL Scale Score, Week 210
|
-16.67 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
GHS/HRQoL Scale Score, Safety Follow-Up Visit
|
-9.85 units of a scale
Standard Deviation 24.10
|
3.85 units of a scale
Standard Deviation 20.30
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Physical Functioning, Week 6
|
-2.93 units of a scale
Standard Deviation 17.69
|
-1.07 units of a scale
Standard Deviation 18.49
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Physical Functioning, Week 12
|
0.17 units of a scale
Standard Deviation 20.35
|
1.46 units of a scale
Standard Deviation 18.07
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Physical Functioning, Week 36
|
6.98 units of a scale
Standard Deviation 19.68
|
-4.90 units of a scale
Standard Deviation 28.33
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Physical Functioning, Week 48
|
7.44 units of a scale
Standard Deviation 18.92
|
2.22 units of a scale
Standard Deviation 19.76
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Physical Functioning, Week 57
|
7.59 units of a scale
Standard Deviation 16.73
|
-3.33 units of a scale
Standard Deviation 20.47
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Physical Functioning, Week 66
|
4.65 units of a scale
Standard Deviation 22.39
|
2.67 units of a scale
Standard Deviation 17.38
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Physical Functioning, Week 93
|
1.67 units of a scale
Standard Deviation 23.38
|
-26.67 units of a scale
Standard Deviation 18.86
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Emotional Functioning, Week 30
|
3.15 units of a scale
Standard Deviation 17.62
|
2.17 units of a scale
Standard Deviation 20.29
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Physical Functioning, Week 111
|
2.38 units of a scale
Standard Deviation 19.67
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Physical Functioning, Week 120
|
3.33 units of a scale
Standard Deviation 20.04
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Physical Functioning, Week 147
|
-0.48 units of a scale
Standard Deviation 17.04
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Physical Functioning, Week 156
|
-4.76 units of a scale
Standard Deviation 10.69
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Role Functioning, Week 111
|
-3.57 units of a scale
Standard Deviation 22.81
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Emotional Functioning, Baseline
|
74.20 units of a scale
Standard Deviation 23.87
|
73.38 units of a scale
Standard Deviation 23.55
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Cognitive Functioning, Week 210
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Social Functioning, Week 111
|
2.38 units of a scale
Standard Deviation 18.32
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Social Functioning, Safety Follow-Up Visit
|
1.52 units of a scale
Standard Deviation 46.22
|
-12.82 units of a scale
Standard Deviation 34.80
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Nausea and Vomiting, Week 165
|
-2.08 units of a scale
Standard Deviation 5.89
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Nausea and Vomiting, Week 192
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Nausea and Vomiting, Week 201
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Insomnia, Week 24
|
-6.23 units of a scale
Standard Deviation 29.01
|
-5.56 units of a scale
Standard Deviation 31.66
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Emotional Functioning, Week 36
|
2.02 units of a scale
Standard Deviation 16.78
|
-5.38 units of a scale
Standard Deviation 21.31
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
GHS/HRQoL Scale Score, Week 111
|
1.79 units of a scale
Standard Deviation 21.73
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
GHS/HRQoL Scale Score, Week 129
|
-2.98 units of a scale
Standard Deviation 19.78
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
GHS/HRQoL Scale Score, Week 147
|
4.17 units of a scale
Standard Deviation 18.42
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
GHS/HRQoL Scale Score, Week 165
|
-3.13 units of a scale
Standard Deviation 23.54
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
GHS/HRQoL Scale Score, Week 174
|
-2.38 units of a scale
Standard Deviation 17.82
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Emotional Functioning, Week 75
|
0.32 units of a scale
Standard Deviation 21.01
|
12.50 units of a scale
Standard Deviation 28.46
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Emotional Functioning, Week 84
|
6.58 units of a scale
Standard Deviation 17.91
|
0.00 units of a scale
Standard Deviation 16.97
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Emotional Functioning, Week 93
|
2.92 units of a scale
Standard Deviation 13.59
|
-4.17 units of a scale
Standard Deviation 5.89
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Emotional Functioning, Week 102
|
4.69 units of a scale
Standard Deviation 12.53
|
-16.67 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Emotional Functioning, Week 111
|
3.57 units of a scale
Standard Deviation 15.92
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Emotional Functioning, Week 120
|
1.79 units of a scale
Standard Deviation 10.93
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Emotional Functioning, Week 129
|
2.98 units of a scale
Standard Deviation 12.91
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Emotional Functioning, Week 138
|
4.17 units of a scale
Standard Deviation 12.97
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Emotional Functioning, Week 147
|
5.36 units of a scale
Standard Deviation 18.08
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Emotional Functioning, Week 156
|
2.38 units of a scale
Standard Deviation 10.45
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Emotional Functioning, Week 165
|
-1.04 units of a scale
Standard Deviation 8.26
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Emotional Functioning, Week 174
|
2.38 units of a scale
Standard Deviation 12.47
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Emotional Functioning, Week 183
|
-1.67 units of a scale
Standard Deviation 10.87
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Emotional Functioning, Week 192
|
-2.08 units of a scale
Standard Deviation 10.49
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Emotional Functioning, Week 201
|
-4.17 units of a scale
Standard Deviation 17.68
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Emotional Functioning, Week 210
|
-16.67 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Emotional Functioning, Safety Follow-Up Visit
|
6.82 units of a scale
Standard Deviation 26.57
|
-5.77 units of a scale
Standard Deviation 21.08
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Cognitive Functioning, Baseline
|
81.39 units of a scale
Standard Deviation 21.49
|
82.65 units of a scale
Standard Deviation 19.95
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Cognitive Functioning, Week 6
|
-1.67 units of a scale
Standard Deviation 21.17
|
-5.94 units of a scale
Standard Deviation 21.76
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Cognitive Functioning, Week 12
|
-1.79 units of a scale
Standard Deviation 22.52
|
-2.60 units of a scale
Standard Deviation 22.27
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Cognitive Functioning, Week 18
|
2.62 units of a scale
Standard Deviation 19.95
|
-7.92 units of a scale
Standard Deviation 24.46
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Cognitive Functioning, Week 24
|
0.48 units of a scale
Standard Deviation 18.41
|
-10.00 units of a scale
Standard Deviation 28.57
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Cognitive Functioning, Week 30
|
-2.01 units of a scale
Standard Deviation 18.11
|
-8.70 units of a scale
Standard Deviation 17.31
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Physical Functioning, Baseline
|
61.34 units of a scale
Standard Deviation 25.66
|
61.97 units of a scale
Standard Deviation 23.75
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Physical Functioning, Week 18
|
3.02 units of a scale
Standard Deviation 17.97
|
-1.58 units of a scale
Standard Deviation 18.00
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Physical Functioning, Week 24
|
3.49 units of a scale
Standard Deviation 18.66
|
-5.50 units of a scale
Standard Deviation 15.64
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Physical Functioning, Week 30
|
4.25 units of a scale
Standard Deviation 18.22
|
-1.23 units of a scale
Standard Deviation 21.80
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Physical Functioning, Week 42
|
3.58 units of a scale
Standard Deviation 24.08
|
0.95 units of a scale
Standard Deviation 16.92
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Cognitive Functioning, Week 36
|
-0.54 units of a scale
Standard Deviation 15.96
|
-11.46 units of a scale
Standard Deviation 16.91
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Cognitive Functioning, Week 42
|
-4.94 units of a scale
Standard Deviation 23.71
|
-7.14 units of a scale
Standard Deviation 12.60
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Cognitive Functioning, Week 48
|
-1.89 units of a scale
Standard Deviation 16.16
|
-11.11 units of a scale
Standard Deviation 14.79
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Cognitive Functioning, Week 57
|
-3.15 units of a scale
Standard Deviation 20.73
|
-2.08 units of a scale
Standard Deviation 16.52
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Cognitive Functioning, Week 66
|
-4.04 units of a scale
Standard Deviation 23.58
|
-3.33 units of a scale
Standard Deviation 18.26
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Cognitive Functioning, Week 75
|
-5.13 units of a scale
Standard Deviation 17.49
|
-4.17 units of a scale
Standard Deviation 20.97
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Cognitive Functioning, Week 84
|
-3.51 units of a scale
Standard Deviation 18.90
|
5.56 units of a scale
Standard Deviation 9.62
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Cognitive Functioning, Week 93
|
3.33 units of a scale
Standard Deviation 12.80
|
0.00 units of a scale
Standard Deviation 0.00
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Cognitive Functioning, Week 102
|
4.17 units of a scale
Standard Deviation 16.67
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Cognitive Functioning, Week 111
|
4.76 units of a scale
Standard Deviation 16.57
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Cognitive Functioning, Week 120
|
0.00 units of a scale
Standard Deviation 20.67
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Cognitive Functioning, Week 129
|
0.00 units of a scale
Standard Deviation 13.07
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Cognitive Functioning, Week 138
|
-2.38 units of a scale
Standard Deviation 20.52
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Cognitive Functioning, Week 147
|
1.19 units of a scale
Standard Deviation 16.62
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Cognitive Functioning, Week 156
|
4.76 units of a scale
Standard Deviation 12.60
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Cognitive Functioning, Week 165
|
6.25 units of a scale
Standard Deviation 12.40
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Cognitive Functioning, Week 174
|
0.00 units of a scale
Standard Deviation 9.62
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Physical Functioning, Week 75
|
4.87 units of a scale
Standard Deviation 27.88
|
-1.67 units of a scale
Standard Deviation 34.16
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Physical Functioning, Week 84
|
3.70 units of a scale
Standard Deviation 23.68
|
-8.89 units of a scale
Standard Deviation 26.94
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Physical Functioning, Week 102
|
2.40 units of a scale
Standard Deviation 16.19
|
-40.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Cognitive Functioning, Week 183
|
3.33 units of a scale
Standard Deviation 18.26
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Cognitive Functioning, Week 192
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Cognitive Functioning, Week 201
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Cognitive Functioning, Safety Follow-Up Visit
|
-16.67 units of a scale
Standard Deviation 23.57
|
5.13 units of a scale
Standard Deviation 25.81
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Social Functioning, Baseline
|
71.32 units of a scale
Standard Deviation 29.12
|
74.43 units of a scale
Standard Deviation 27.62
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Social Functioning, Week 6
|
1.30 units of a scale
Standard Deviation 27.66
|
-4.49 units of a scale
Standard Deviation 28.30
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Social Functioning, Week 12
|
1.58 units of a scale
Standard Deviation 27.93
|
-4.17 units of a scale
Standard Deviation 32.93
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Social Functioning, Week 18
|
5.60 units of a scale
Standard Deviation 24.38
|
-14.17 units of a scale
Standard Deviation 31.93
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Social Functioning, Week 24
|
5.08 units of a scale
Standard Deviation 24.91
|
-11.11 units of a scale
Standard Deviation 27.45
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Social Functioning, Week 30
|
4.82 units of a scale
Standard Deviation 23.79
|
-5.80 units of a scale
Standard Deviation 36.10
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Social Functioning, Week 36
|
3.01 units of a scale
Standard Deviation 27.97
|
-14.58 units of a scale
Standard Deviation 42.11
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Social Functioning, Week 42
|
-0.31 units of a scale
Standard Deviation 26.79
|
-7.14 units of a scale
Standard Deviation 36.23
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Social Functioning, Week 48
|
1.89 units of a scale
Standard Deviation 21.93
|
-5.56 units of a scale
Standard Deviation 28.72
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Social Functioning, Week 57
|
3.60 units of a scale
Standard Deviation 29.17
|
2.08 units of a scale
Standard Deviation 30.13
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Social Functioning, Week 66
|
5.56 units of a scale
Standard Deviation 26.90
|
3.33 units of a scale
Standard Deviation 29.81
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Social Functioning, Week 75
|
5.77 units of a scale
Standard Deviation 23.07
|
4.17 units of a scale
Standard Deviation 34.36
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Social Functioning, Week 84
|
2.63 units of a scale
Standard Deviation 21.70
|
22.22 units of a scale
Standard Deviation 25.46
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Physical Functioning, Week 129
|
-1.03 units of a scale
Standard Deviation 19.02
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Physical Functioning, Week 138
|
-0.48 units of a scale
Standard Deviation 19.47
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Social Functioning, Week 93
|
8.33 units of a scale
Standard Deviation 16.67
|
8.33 units of a scale
Standard Deviation 11.79
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Social Functioning, Week 102
|
9.38 units of a scale
Standard Deviation 17.18
|
16.67 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Social Functioning, Week 120
|
7.14 units of a scale
Standard Deviation 14.19
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Social Functioning, Week 129
|
-2.38 units of a scale
Standard Deviation 30.56
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Social Functioning, Week 138
|
2.38 units of a scale
Standard Deviation 20.52
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Social Functioning, Week 147
|
7.14 units of a scale
Standard Deviation 16.94
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Social Functioning, Week 156
|
4.76 units of a scale
Standard Deviation 15.85
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Social Functioning, Week 165
|
-6.25 units of a scale
Standard Deviation 29.46
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Social Functioning, Week 174
|
7.14 units of a scale
Standard Deviation 26.97
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Physical Functioning, Week 165
|
-3.61 units of a scale
Standard Deviation 13.44
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Physical Functioning, Week 174
|
-1.90 units of a scale
Standard Deviation 21.33
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Physical Functioning, Week 183
|
2.67 units of a scale
Standard Deviation 19.21
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Physical Functioning, Week 192
|
-3.33 units of a scale
Standard Deviation 12.77
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Physical Functioning, Week 201
|
-3.33 units of a scale
Standard Deviation 4.71
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Physical Functioning, Week 210
|
-20.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Physical Functioning, Safety Follow-Up Visit
|
-9.70 units of a scale
Standard Deviation 25.01
|
-6.67 units of a scale
Standard Deviation 27.08
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Role Functioning, Baseline
|
62.53 units of a scale
Standard Deviation 33.17
|
61.72 units of a scale
Standard Deviation 34.31
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Role Functioning, Week 6
|
-2.63 units of a scale
Standard Deviation 28.13
|
-3.51 units of a scale
Standard Deviation 30.12
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Role Functioning, Week 12
|
-1.78 units of a scale
Standard Deviation 30.48
|
-1.59 units of a scale
Standard Deviation 26.56
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Role Functioning, Week 18
|
-0.96 units of a scale
Standard Deviation 30.02
|
1.71 units of a scale
Standard Deviation 36.63
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Role Functioning, Week 24
|
1.25 units of a scale
Standard Deviation 30.00
|
-5.00 units of a scale
Standard Deviation 28.42
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Role Functioning, Week 30
|
-0.20 units of a scale
Standard Deviation 29.10
|
-7.25 units of a scale
Standard Deviation 32.50
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Role Functioning, Week 36
|
2.15 units of a scale
Standard Deviation 35.00
|
-14.58 units of a scale
Standard Deviation 47.09
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Role Functioning, Week 42
|
1.54 units of a scale
Standard Deviation 35.95
|
-4.76 units of a scale
Standard Deviation 47.78
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Role Functioning, Week 48
|
4.92 units of a scale
Standard Deviation 29.55
|
-2.78 units of a scale
Standard Deviation 34.69
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Role Functioning, Week 57
|
3.15 units of a scale
Standard Deviation 28.82
|
-4.17 units of a scale
Standard Deviation 19.42
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Role Functioning, Week 66
|
0.51 units of a scale
Standard Deviation 25.17
|
-6.67 units of a scale
Standard Deviation 25.28
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Role Functioning, Week 75
|
-0.64 units of a scale
Standard Deviation 31.44
|
8.33 units of a scale
Standard Deviation 48.11
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Role Functioning, Week 84
|
3.70 units of a scale
Standard Deviation 16.72
|
-11.11 units of a scale
Standard Deviation 19.25
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Role Functioning, Week 93
|
-1.67 units of a scale
Standard Deviation 26.98
|
-25.00 units of a scale
Standard Deviation 35.36
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Role Functioning, Week 102
|
2.08 units of a scale
Standard Deviation 18.13
|
-33.33 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Role Functioning, Week 120
|
-1.19 units of a scale
Standard Deviation 19.02
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Role Functioning, Week 129
|
-1.19 units of a scale
Standard Deviation 17.86
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Role Functioning, Week 138
|
-2.38 units of a scale
Standard Deviation 22.51
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Role Functioning, Week 147
|
-3.57 units of a scale
Standard Deviation 17.52
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Role Functioning, Week 156
|
-2.38 units of a scale
Standard Deviation 6.30
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Role Functioning, Week 165
|
-10.42 units of a scale
Standard Deviation 26.63
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Role Functioning, Week 174
|
-7.14 units of a scale
Standard Deviation 26.97
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Role Functioning, Week 183
|
-10.00 units of a scale
Standard Deviation 9.13
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Role Functioning, Week 192
|
-16.67 units of a scale
Standard Deviation 13.61
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Role Functioning, Week 201
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Role Functioning, Week 210
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Role Functioning, Safety Follow-Up Visit
|
-22.73 units of a scale
Standard Deviation 41.01
|
-1.28 units of a scale
Standard Deviation 43.28
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Social Functioning, Week 183
|
6.67 units of a scale
Standard Deviation 38.37
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Social Functioning, Week 192
|
-4.17 units of a scale
Standard Deviation 28.46
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Social Functioning, Week 201
|
-25.00 units of a scale
Standard Deviation 35.36
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Social Functioning, Week 210
|
-50.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Emotional Functioning, Week 6
|
2.12 units of a scale
Standard Deviation 20.59
|
0.46 units of a scale
Standard Deviation 23.00
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Fatigue, Baseline
|
41.62 units of a scale
Standard Deviation 26.98
|
42.62 units of a scale
Standard Deviation 25.10
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Fatigue, Week 6
|
3.37 units of a scale
Standard Deviation 23.32
|
2.08 units of a scale
Standard Deviation 23.71
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Fatigue, Week 12
|
0.53 units of a scale
Standard Deviation 26.98
|
-1.56 units of a scale
Standard Deviation 22.99
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Fatigue, Week 18
|
-1.79 units of a scale
Standard Deviation 22.11
|
2.22 units of a scale
Standard Deviation 18.69
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Fatigue, Week 24
|
-3.14 units of a scale
Standard Deviation 25.82
|
2.96 units of a scale
Standard Deviation 21.43
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Emotional Functioning, Week 12
|
1.24 units of a scale
Standard Deviation 21.06
|
4.21 units of a scale
Standard Deviation 22.77
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Fatigue, Week 30
|
-2.88 units of a scale
Standard Deviation 22.98
|
-3.38 units of a scale
Standard Deviation 24.03
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Fatigue, Week 36
|
-4.06 units of a scale
Standard Deviation 28.12
|
4.86 units of a scale
Standard Deviation 27.81
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Emotional Functioning, Week 18
|
3.82 units of a scale
Standard Deviation 18.23
|
0.28 units of a scale
Standard Deviation 22.10
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Emotional Functioning, Week 42
|
2.01 units of a scale
Standard Deviation 19.08
|
-7.14 units of a scale
Standard Deviation 16.30
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Emotional Functioning, Week 48
|
5.04 units of a scale
Standard Deviation 13.87
|
-3.47 units of a scale
Standard Deviation 10.33
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Emotional Functioning, Week 57
|
5.78 units of a scale
Standard Deviation 20.58
|
3.13 units of a scale
Standard Deviation 23.12
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Emotional Functioning, Week 66
|
4.29 units of a scale
Standard Deviation 17.81
|
6.67 units of a scale
Standard Deviation 6.97
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Fatigue, Week 42
|
-2.67 units of a scale
Standard Deviation 29.11
|
3.17 units of a scale
Standard Deviation 28.05
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Fatigue, Week 48
|
-6.72 units of a scale
Standard Deviation 24.86
|
1.85 units of a scale
Standard Deviation 23.61
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Fatigue, Week 57
|
-3.30 units of a scale
Standard Deviation 22.66
|
1.39 units of a scale
Standard Deviation 18.25
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Fatigue, Week 66
|
-2.53 units of a scale
Standard Deviation 29.63
|
-6.67 units of a scale
Standard Deviation 12.67
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Fatigue, Week 75
|
-4.70 units of a scale
Standard Deviation 22.26
|
-8.33 units of a scale
Standard Deviation 33.18
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Fatigue, Week 84
|
-6.79 units of a scale
Standard Deviation 26.72
|
22.22 units of a scale
Standard Deviation 19.25
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Fatigue, Week 93
|
-5.56 units of a scale
Standard Deviation 30.05
|
22.22 units of a scale
Standard Deviation 0.00
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Fatigue, Week 102
|
-5.56 units of a scale
Standard Deviation 26.91
|
33.33 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Fatigue, Week 111
|
-0.79 units of a scale
Standard Deviation 33.32
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Fatigue, Week 120
|
-2.38 units of a scale
Standard Deviation 28.30
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Fatigue, Week 129
|
-2.78 units of a scale
Standard Deviation 18.33
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Fatigue, Week 138
|
-1.59 units of a scale
Standard Deviation 26.10
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Fatigue, Week 147
|
-3.17 units of a scale
Standard Deviation 25.94
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Fatigue, Week 156
|
-1.59 units of a scale
Standard Deviation 14.95
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Fatigue, Week 165
|
1.39 units of a scale
Standard Deviation 29.95
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Fatigue, Week 174
|
-4.76 units of a scale
Standard Deviation 20.14
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Fatigue, Week 183
|
4.44 units of a scale
Standard Deviation 26.76
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Fatigue, Week 192
|
5.56 units of a scale
Standard Deviation 14.34
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Fatigue, Week 201
|
-5.56 units of a scale
Standard Deviation 7.86
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Fatigue, Week 210
|
-11.11 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Fatigue, Safety Follow-Up Visit
|
0.00 units of a scale
Standard Deviation 31.82
|
1.71 units of a scale
Standard Deviation 33.59
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Dyspnoea, Week 75
|
-5.13 units of a scale
Standard Deviation 22.49
|
-16.67 units of a scale
Standard Deviation 19.25
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Nausea and Vomiting, Baseline
|
8.28 units of a scale
Standard Deviation 17.07
|
7.99 units of a scale
Standard Deviation 15.06
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Nausea and Vomiting, Week 6
|
0.90 units of a scale
Standard Deviation 16.98
|
1.01 units of a scale
Standard Deviation 19.28
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Nausea and Vomiting, Week 12
|
1.12 units of a scale
Standard Deviation 17.72
|
3.65 units of a scale
Standard Deviation 16.92
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Nausea and Vomiting, Week 18
|
-0.41 units of a scale
Standard Deviation 15.67
|
3.33 units of a scale
Standard Deviation 18.18
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Dyspnoea, Week 84
|
-9.26 units of a scale
Standard Deviation 25.06
|
0.00 units of a scale
Standard Deviation 0.00
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Nausea and Vomiting, Week 24
|
-1.87 units of a scale
Standard Deviation 14.54
|
3.33 units of a scale
Standard Deviation 16.02
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Dyspnoea, Week 93
|
0.00 units of a scale
Standard Deviation 35.87
|
-16.67 units of a scale
Standard Deviation 23.57
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Nausea and Vomiting, Week 30
|
-2.38 units of a scale
Standard Deviation 16.39
|
3.62 units of a scale
Standard Deviation 10.0063
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Nausea and Vomiting, Week 36
|
2.12 units of a scale
Standard Deviation 17.32
|
3.13 units of a scale
Standard Deviation 15.18
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Nausea and Vomiting, Week 42
|
1.54 units of a scale
Standard Deviation 11.79
|
3.57 units of a scale
Standard Deviation 19.81
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Nausea and Vomiting, Week 48
|
-1.55 units of a scale
Standard Deviation 15.78
|
0.00 units of a scale
Standard Deviation 20.10
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Nausea and Vomiting, Week 57
|
2.25 units of a scale
Standard Deviation 11.89
|
2.08 units of a scale
Standard Deviation 18.77
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Nausea and Vomiting, Week 66
|
-1.01 units of a scale
Standard Deviation 14.99
|
-3.33 units of a scale
Standard Deviation 7.45
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Nausea and Vomiting, Week 75
|
2.56 units of a scale
Standard Deviation 9.06
|
-4.17 units of a scale
Standard Deviation 8.33
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Nausea and Vomiting, Week 84
|
0.88 units of a scale
Standard Deviation 8.74
|
0.00 units of a scale
Standard Deviation 16.67
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Nausea and Vomiting, Week 93
|
-1.67 units of a scale
Standard Deviation 5.13
|
-8.33 units of a scale
Standard Deviation 11.79
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Nausea and Vomiting, Week 102
|
-2.08 units of a scale
Standard Deviation 5.69
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Nausea and Vomiting, Week 111
|
4.76 units of a scale
Standard Deviation 12.10
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Nausea and Vomiting, Week 120
|
-1.19 units of a scale
Standard Deviation 7.91
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Nausea and Vomiting, Week 129
|
0.00 units of a scale
Standard Deviation 6.54
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Nausea and Vomiting, Week 138
|
-2.38 units of a scale
Standard Deviation 6.05
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Nausea and Vomiting, Week 147
|
-2.38 units of a scale
Standard Deviation 6.05
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Nausea and Vomiting, Week 156
|
-2.38 units of a scale
Standard Deviation 6.30
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Nausea and Vomiting, Week 174
|
-2.38 units of a scale
Standard Deviation 6.30
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Nausea and Vomiting, Week 183
|
-3.33 units of a scale
Standard Deviation 7.45
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Nausea and Vomiting, Week 210
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Nausea and Vomiting, Safety Follow-Up Visit
|
13.64 units of a scale
Standard Deviation 42.04
|
0.00 units of a scale
Standard Deviation 33.33
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Pain, Baseline
|
31.52 units of a scale
Standard Deviation 29.67
|
32.99 units of a scale
Standard Deviation 29.06
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Pain, Week 6
|
-0.98 units of a scale
Standard Deviation 25.27
|
-1.01 units of a scale
Standard Deviation 26.61
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Pain, Week 12
|
-3.58 units of a scale
Standard Deviation 29.67
|
-5.73 units of a scale
Standard Deviation 27.09
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Pain, Week 18
|
-5.51 units of a scale
Standard Deviation 30.38
|
3.75 units of a scale
Standard Deviation 31.23
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Pain, Week 24
|
-6.70 units of a scale
Standard Deviation 30.01
|
3.89 units of a scale
Standard Deviation 23.44
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Pain, Week 30
|
-5.36 units of a scale
Standard Deviation 30.30
|
-9.42 units of a scale
Standard Deviation 21.80
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Pain, Week 36
|
-7.41 units of a scale
Standard Deviation 28.36
|
3.13 units of a scale
Standard Deviation 25.25
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Pain, Week 42
|
-5.25 units of a scale
Standard Deviation 33.77
|
-4.76 units of a scale
Standard Deviation 33.61
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Pain, Week 48
|
-9.85 units of a scale
Standard Deviation 30.57
|
-11.11 units of a scale
Standard Deviation 26.91
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Pain, Week 57
|
-7.21 units of a scale
Standard Deviation 31.80
|
-6.25 units of a scale
Standard Deviation 25.10
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Pain, Week 66
|
-13.13 units of a scale
Standard Deviation 30.26
|
-20.00 units of a scale
Standard Deviation 21.73
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Pain, Week 75
|
-5.77 units of a scale
Standard Deviation 33.65
|
0.00 units of a scale
Standard Deviation 36.00
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Pain, Week 84
|
-15.79 units of a scale
Standard Deviation 26.34
|
-11.11 units of a scale
Standard Deviation 19.25
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Pain, Week 93
|
-7.50 units of a scale
Standard Deviation 27.29
|
-16.67 units of a scale
Standard Deviation 23.57
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Pain, Week 102
|
-17.71 units of a scale
Standard Deviation 25.44
|
-33.33 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Pain, Week 111
|
-14.29 units of a scale
Standard Deviation 23.44
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Pain, Week 120
|
-15.48 units of a scale
Standard Deviation 26.53
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Pain, Week 129
|
-10.71 units of a scale
Standard Deviation 16.80
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Pain, Week 138
|
-15.48 units of a scale
Standard Deviation 25.71
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Pain, Week 147
|
-13.10 units of a scale
Standard Deviation 27.87
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Pain, Week 156
|
-14.29 units of a scale
Standard Deviation 20.25
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Pain, Week 165
|
-10.42 units of a scale
Standard Deviation 19.80
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Pain, Week 174
|
-11.90 units of a scale
Standard Deviation 34.31
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Dyspnoea, Week 102
|
4.17 units of a scale
Standard Deviation 26.87
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Pain, Week 183
|
-13.33 units of a scale
Standard Deviation 36.13
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Pain, Week 192
|
-12.50 units of a scale
Standard Deviation 25.00
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Pain, Week 201
|
-25.00 units of a scale
Standard Deviation 35.36
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Pain, Week 210
|
-16.67 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Pain, Safety Follow-Up Visit
|
9.09 units of a scale
Standard Deviation 26.21
|
-7.69 units of a scale
Standard Deviation 38.26
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Dyspnoea, Baseline
|
36.17 units of a scale
Standard Deviation 30.47
|
39.31 units of a scale
Standard Deviation 31.35
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Dyspnoea, Week 6
|
-1.36 units of a scale
Standard Deviation 28.55
|
-0.58 units of a scale
Standard Deviation 29.74
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Dyspnoea, Week 111
|
-7.69 units of a scale
Standard Deviation 33.76
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Dyspnoea, Week 12
|
0.45 units of a scale
Standard Deviation 30.51
|
-4.69 units of a scale
Standard Deviation 27.13
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Dyspnoea, Week 18
|
-1.91 units of a scale
Standard Deviation 26.87
|
-3.33 units of a scale
Standard Deviation 31.85
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Dyspnoea, Week 24
|
-5.03 units of a scale
Standard Deviation 29.02
|
-4.44 units of a scale
Standard Deviation 29.99
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Dyspnoea, Week 30
|
-4.37 units of a scale
Standard Deviation 28.24
|
-8.70 units of a scale
Standard Deviation 30.51
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Dyspnoea, Week 36
|
-6.99 units of a scale
Standard Deviation 27.08
|
0.00 units of a scale
Standard Deviation 34.43
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Dyspnoea, Week 42
|
-8.64 units of a scale
Standard Deviation 32.50
|
-7.69 units of a scale
Standard Deviation 19.97
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Dyspnoea, Week 48
|
-7.58 units of a scale
Standard Deviation 30.38
|
-3.03 units of a scale
Standard Deviation 23.35
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Dyspnoea, Week 57
|
-9.01 units of a scale
Standard Deviation 30.07
|
-12.50 units of a scale
Standard Deviation 24.80
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Dyspnoea, Week 66
|
-3.03 units of a scale
Standard Deviation 30.46
|
-20.00 units of a scale
Standard Deviation 18.26
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Constipation, Safety Follow-Up Visit
|
3.03 units of a scale
Standard Deviation 45.84
|
7.69 units of a scale
Standard Deviation 30.89
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Dyspnoea, Week 120
|
0.00 units of a scale
Standard Deviation 22.65
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Dyspnoea, Week 129
|
2.38 units of a scale
Standard Deviation 24.33
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Dyspnoea, Week 138
|
-2.38 units of a scale
Standard Deviation 27.62
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Dyspnoea, Week 147
|
-4.76 units of a scale
Standard Deviation 22.10
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Dyspnoea, Week 156
|
0.00 units of a scale
Standard Deviation 19.25
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Dyspnoea, Week 165
|
-4.17 units of a scale
Standard Deviation 21.36
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Dyspnoea, Week 174
|
4.76 units of a scale
Standard Deviation 23.00
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Dyspnoea, Week 183
|
6.67 units of a scale
Standard Deviation 27.89
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Dyspnoea, Week 192
|
0.00 units of a scale
Standard Deviation 27.22
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Dyspnoea, Week 201
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Dyspnoea, Week 210
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Dyspnoea, Safety Follow-Up Visit
|
24.24 units of a scale
Standard Deviation 44.95
|
-2.78 units of a scale
Standard Deviation 43.71
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Insomnia, Baseline
|
30.50 units of a scale
Standard Deviation 29.97
|
31.05 units of a scale
Standard Deviation 32.44
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Insomnia, Week 6
|
-1.95 units of a scale
Standard Deviation 31.25
|
-1.16 units of a scale
Standard Deviation 33.60
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Insomnia, Week 12
|
-1.78 units of a scale
Standard Deviation 31.32
|
-3.65 units of a scale
Standard Deviation 33.13
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Insomnia, Week 18
|
-4.37 units of a scale
Standard Deviation 27.76
|
-2.50 units of a scale
Standard Deviation 36.51
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Insomnia, Week 30
|
-3.17 units of a scale
Standard Deviation 26.19
|
-15.94 units of a scale
Standard Deviation 28.19
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Insomnia, Week 36
|
-3.17 units of a scale
Standard Deviation 26.58
|
-18.75 units of a scale
Standard Deviation 34.36
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Insomnia, Week 42
|
-3.09 units of a scale
Standard Deviation 36.21
|
-9.52 units of a scale
Standard Deviation 27.51
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Insomnia, Week 48
|
-6.20 units of a scale
Standard Deviation 27.46
|
2.78 units of a scale
Standard Deviation 26.43
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Insomnia, Week 57
|
-9.91 units of a scale
Standard Deviation 32.27
|
4.17 units of a scale
Standard Deviation 33.03
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Insomnia, Week 66
|
-8.08 units of a scale
Standard Deviation 27.68
|
-6.67 units of a scale
Standard Deviation 14.91
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Insomnia, Week 75
|
-8.97 units of a scale
Standard Deviation 27.58
|
-16.67 units of a scale
Standard Deviation 19.25
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Insomnia, Week 84
|
-7.41 units of a scale
Standard Deviation 24.40
|
-22.22 units of a scale
Standard Deviation 19.25
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Insomnia, Week 93
|
-8.33 units of a scale
Standard Deviation 23.88
|
0.00 units of a scale
Standard Deviation 0.00
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Insomnia, Week 102
|
-10.42 units of a scale
Standard Deviation 20.07
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Insomnia, Week 111
|
-9.52 units of a scale
Standard Deviation 20.37
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Insomnia, Week 120
|
-11.90 units of a scale
Standard Deviation 21.11
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Insomnia, Week 129
|
-9.52 units of a scale
Standard Deviation 20.37
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Insomnia, Week 138
|
-16.67 units of a scale
Standard Deviation 21.68
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Insomnia, Week 147
|
-14.29 units of a scale
Standard Deviation 28.39
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Insomnia, Week 156
|
-4.76 units of a scale
Standard Deviation 12.60
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Insomnia, Week 165
|
0.00 units of a scale
Standard Deviation 17.82
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Insomnia, Week 174
|
-9.52 units of a scale
Standard Deviation 16.27
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Insomnia, Week 183
|
-13.33 units of a scale
Standard Deviation 38.01
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Insomnia, Week 192
|
-8.33 units of a scale
Standard Deviation 16.67
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Insomnia, Week 201
|
-33.33 units of a scale
Standard Deviation 47.14
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Insomnia, Week 210
|
-33.33 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Insomnia, Safety Follow-Up Visit
|
12.12 units of a scale
Standard Deviation 42.88
|
-5.13 units of a scale
Standard Deviation 35.61
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Appetite Loss, Baseline
|
31.63 units of a scale
Standard Deviation 33.06
|
31.05 units of a scale
Standard Deviation 32.91
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Appetite Loss, Week 6
|
1.06 units of a scale
Standard Deviation 33.99
|
0.00 units of a scale
Standard Deviation 38.40
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Appetite Loss, Week 12
|
-4.22 units of a scale
Standard Deviation 35.46
|
7.29 units of a scale
Standard Deviation 32.24
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Appetite Loss, Week 18
|
-7.38 units of a scale
Standard Deviation 33.06
|
13.33 units of a scale
Standard Deviation 27.01
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Appetite Loss, Week 24
|
-9.43 units of a scale
Standard Deviation 28.27
|
10.00 units of a scale
Standard Deviation 32.93
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Appetite Loss, Week 30
|
-12.30 units of a scale
Standard Deviation 28.24
|
7.25 units of a scale
Standard Deviation 31.71
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Appetite Loss, Week 36
|
-11.11 units of a scale
Standard Deviation 33.87
|
6.25 units of a scale
Standard Deviation 30.35
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Appetite Loss, Week 42
|
-7.41 units of a scale
Standard Deviation 32.81
|
2.38 units of a scale
Standard Deviation 27.62
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Appetite Loss, Week 48
|
-10.85 units of a scale
Standard Deviation 29.74
|
5.56 units of a scale
Standard Deviation 44.57
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Appetite Loss, Week 57
|
-6.31 units of a scale
Standard Deviation 31.27
|
8.33 units of a scale
Standard Deviation 42.72
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Appetite Loss, Week 66
|
-9.09 units of a scale
Standard Deviation 29.19
|
13.33 units of a scale
Standard Deviation 29.81
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Appetite Loss, Week 75
|
-10.26 units of a scale
Standard Deviation 30.94
|
0.00 units of a scale
Standard Deviation 27.22
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Appetite Loss, Week 84
|
-17.54 units of a scale
Standard Deviation 28.04
|
22.22 units of a scale
Standard Deviation 19.25
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Appetite Loss, Week 93
|
-10.00 units of a scale
Standard Deviation 26.71
|
50.00 units of a scale
Standard Deviation 23.57
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Appetite Loss, Week 102
|
-10.42 units of a scale
Standard Deviation 20.07
|
66.67 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Appetite Loss, Week 111
|
-7.14 units of a scale
Standard Deviation 23.31
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Appetite Loss, Week 120
|
-9.52 units of a scale
Standard Deviation 27.51
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Appetite Loss, Week 129
|
-7.14 units of a scale
Standard Deviation 23.31
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Appetite Loss, Week 138
|
-9.52 units of a scale
Standard Deviation 24.21
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Appetite Loss, Week 147
|
-16.67 units of a scale
Standard Deviation 31.35
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Appetite Loss, Week 156
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Appetite Loss, Week 165
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Appetite Loss, Week 174
|
-9.52 units of a scale
Standard Deviation 25.20
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Appetite Loss, Week 183
|
-13.33 units of a scale
Standard Deviation 29.81
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Appetite Loss, Week 192
|
8.33 units of a scale
Standard Deviation 16.67
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Appetite Loss, Week 201
|
16.67 units of a scale
Standard Deviation 23.57
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Appetite Loss, Week 210
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Appetite Loss, Safety Follow-Up Visit
|
-9.09 units of a scale
Standard Deviation 39.70
|
-7.69 units of a scale
Standard Deviation 52.97
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Constipation, Baseline
|
21.20 units of a scale
Standard Deviation 30.67
|
21.92 units of a scale
Standard Deviation 27.80
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Constipation, Week 6
|
-0.45 units of a scale
Standard Deviation 27.98
|
1.45 units of a scale
Standard Deviation 31.65
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Constipation, Week 12
|
-2.46 units of a scale
Standard Deviation 29.79
|
-0.52 units of a scale
Standard Deviation 28.17
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Constipation, Week 18
|
-6.01 units of a scale
Standard Deviation 29.39
|
0.83 units of a scale
Standard Deviation 29.71
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Constipation, Week 24
|
-5.61 units of a scale
Standard Deviation 29.13
|
1.11 units of a scale
Standard Deviation 22.29
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Constipation, Week 30
|
-6.75 units of a scale
Standard Deviation 27.76
|
5.80 units of a scale
Standard Deviation 25.92
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Constipation, Week 36
|
-7.94 units of a scale
Standard Deviation 33.18
|
6.25 units of a scale
Standard Deviation 18.13
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Constipation, Week 42
|
-4.94 units of a scale
Standard Deviation 31.33
|
0.00 units of a scale
Standard Deviation 18.49
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Constipation, Week 48
|
-10.61 units of a scale
Standard Deviation 32.76
|
-6.06 units of a scale
Standard Deviation 25.03
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Constipation, Week 57
|
-15.32 units of a scale
Standard Deviation 28.97
|
-8.33 units of a scale
Standard Deviation 15.43
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Constipation, Week 66
|
-13.13 units of a scale
Standard Deviation 27.56
|
0.00 units of a scale
Standard Deviation 23.57
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Constipation, Week 75
|
-5.13 units of a scale
Standard Deviation 32.24
|
16.67 units of a scale
Standard Deviation 57.74
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Constipation, Week 84
|
-3.51 units of a scale
Standard Deviation 31.22
|
11.11 units of a scale
Standard Deviation 38.49
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Constipation, Week 93
|
-8.33 units of a scale
Standard Deviation 35.66
|
33.33 units of a scale
Standard Deviation 0.00
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Constipation, Week 102
|
-10.42 units of a scale
Standard Deviation 35.94
|
33.33 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Constipation, Week 111
|
-7.14 units of a scale
Standard Deviation 41.71
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Constipation, Week 120
|
-4.76 units of a scale
Standard Deviation 41.05
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Constipation, Week 129
|
-7.14 units of a scale
Standard Deviation 41.71
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Constipation, Week 138
|
-9.52 units of a scale
Standard Deviation 47.91
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Constipation, Week 147
|
-11.90 units of a scale
Standard Deviation 42.58
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Constipation, Week 156
|
-14.29 units of a scale
Standard Deviation 26.23
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Constipation, Week 165
|
-8.33 units of a scale
Standard Deviation 29.55
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Constipation, Week 174
|
-14.29 units of a scale
Standard Deviation 26.23
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Constipation, Week 183
|
-13.33 units of a scale
Standard Deviation 18.26
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Constipation, Week 192
|
0.00 units of a scale
Standard Deviation 27.22
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Constipation, Week 201
|
16.67 units of a scale
Standard Deviation 23.57
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Constipation, Week 210
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Diarrhoea, Week 18
|
-0.83 units of a scale
Standard Deviation 18.57
|
5.83 units of a scale
Standard Deviation 24.91
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Diarrhoea, Week 24
|
0.00 units of a scale
Standard Deviation 18.58
|
5.56 units of a scale
Standard Deviation 17.69
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Diarrhoea, Week 30
|
2.01 units of a scale
Standard Deviation 19.02
|
4.35 units of a scale
Standard Deviation 11.48
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Diarrhoea, Week 36
|
0.00 units of a scale
Standard Deviation 20.91
|
2.08 units of a scale
Standard Deviation 8.33
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Diarrhoea, Week 42
|
-3.09 units of a scale
Standard Deviation 17.46
|
2.38 units of a scale
Standard Deviation 8.91
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Diarrhoea, Week 48
|
-0.76 units of a scale
Standard Deviation 15.23
|
8.33 units of a scale
Standard Deviation 20.72
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Diarrhoea, Week 57
|
0.00 units of a scale
Standard Deviation 20.79
|
4.17 units of a scale
Standard Deviation 11.79
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Diarrhoea, Week 66
|
-4.04 units of a scale
Standard Deviation 18.18
|
6.67 units of a scale
Standard Deviation 14.91
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Diarrhoea, Week 75
|
-5.13 units of a scale
Standard Deviation 15.47
|
0.00 units of a scale
Standard Deviation 0.00
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Diarrhoea, Week 84
|
1.75 units of a scale
Standard Deviation 13.49
|
0.00 units of a scale
Standard Deviation 0.00
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Diarrhoea, Week 93
|
1.67 units of a scale
Standard Deviation 25.31
|
0.00 units of a scale
Standard Deviation 0.00
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Diarrhoea, Week 102
|
0.00 units of a scale
Standard Deviation 17.21
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Diarrhoea, Week 111
|
7.14 units of a scale
Standard Deviation 29.75
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Diarrhoea, Week 120
|
4.76 units of a scale
Standard Deviation 34.24
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Diarrhoea, Week 129
|
2.38 units of a scale
Standard Deviation 33.24
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Diarrhoea, Week 138
|
-4.76 units of a scale
Standard Deviation 17.82
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Diarrhoea, Week 147
|
-4.76 units of a scale
Standard Deviation 22.10
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Diarrhoea, Week 156
|
-4.76 units of a scale
Standard Deviation 12.60
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Diarrhoea, Week 165
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Diarrhoea, Week 174
|
-9.52 units of a scale
Standard Deviation 25.20
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Diarrhoea, Week 183
|
-13.33 units of a scale
Standard Deviation 29.81
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Diarrhoea, Week 192
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Diarrhoea, Week 201
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Diarrhoea, Week 210
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Diarrhoea, Safety Follow-Up Visit
|
6.06 units of a scale
Standard Deviation 29.13
|
0.00 units of a scale
Standard Deviation 13.61
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Financial Difficulties, Baseline
|
22.22 units of a scale
Standard Deviation 28.81
|
20.32 units of a scale
Standard Deviation 28.60
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Financial Difficulties, Week 6
|
-3.20 units of a scale
Standard Deviation 27.00
|
0.00 units of a scale
Standard Deviation 25.74
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Financial Difficulties, Week 12
|
-4.95 units of a scale
Standard Deviation 27.59
|
1.56 units of a scale
Standard Deviation 26.18
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Financial Difficulties, Week 18
|
-4.41 units of a scale
Standard Deviation 23.94
|
4.17 units of a scale
Standard Deviation 27.41
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Financial Difficulties, Week 24
|
-4.76 units of a scale
Standard Deviation 30.11
|
2.22 units of a scale
Standard Deviation 23.05
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Financial Difficulties, Week 30
|
-3.21 units of a scale
Standard Deviation 24.20
|
-1.45 units of a scale
Standard Deviation 23.52
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Financial Difficulties, Week 36
|
-2.69 units of a scale
Standard Deviation 28.50
|
4.44 units of a scale
Standard Deviation 21.33
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Financial Difficulties, Week 42
|
-1.85 units of a scale
Standard Deviation 33.28
|
2.38 units of a scale
Standard Deviation 27.62
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Financial Difficulties, Week 48
|
-0.76 units of a scale
Standard Deviation 29.19
|
-5.56 units of a scale
Standard Deviation 27.83
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Financial Difficulties, Week 57
|
-4.50 units of a scale
Standard Deviation 32.55
|
-4.17 units of a scale
Standard Deviation 21.36
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Financial Difficulties, Week 66
|
0.00 units of a scale
Standard Deviation 28.87
|
-6.67 units of a scale
Standard Deviation 27.89
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Financial Difficulties, Week 75
|
1.28 units of a scale
Standard Deviation 29.03
|
8.33 units of a scale
Standard Deviation 31.91
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Financial Difficulties, Week 84
|
3.51 units of a scale
Standard Deviation 26.98
|
-22.22 units of a scale
Standard Deviation 19.25
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Financial Difficulties, Week 93
|
0.00 units of a scale
Standard Deviation 26.49
|
-16.67 units of a scale
Standard Deviation 23.57
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Financial Difficulties, Week 102
|
2.08 units of a scale
Standard Deviation 25.73
|
-33.33 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Financial Difficulties, Week 111
|
2.38 units of a scale
Standard Deviation 27.62
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Financial Difficulties, Week 120
|
-2.38 units of a scale
Standard Deviation 27.62
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Financial Difficulties, Week 129
|
-2.38 units of a scale
Standard Deviation 24.33
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Financial Difficulties, Week 138
|
2.38 units of a scale
Standard Deviation 30.56
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Financial Difficulties, Week 147
|
-2.38 units of a scale
Standard Deviation 27.62
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Financial Difficulties, Week 156
|
-9.52 units of a scale
Standard Deviation 31.71
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Financial Difficulties, Week 165
|
4.17 units of a scale
Standard Deviation 37.53
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Financial Difficulties, Week 174
|
-9.52 units of a scale
Standard Deviation 31.71
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Financial Difficulties, Week 183
|
0.00 units of a scale
Standard Deviation 23.57
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Financial Difficulties, Week 192
|
0.00 units of a scale
Standard Deviation 27.22
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Financial Difficulties, Week 201
|
16.67 units of a scale
Standard Deviation 23.57
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Financial Difficulties, Week 210
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Financial Difficulties, Safety Follow-Up Visit
|
-3.03 units of a scale
Standard Deviation 43.34
|
0.00 units of a scale
Standard Deviation 27.22
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Diarrhoea, Baseline
|
5.63 units of a scale
Standard Deviation 15.28
|
5.71 units of a scale
Standard Deviation 16.31
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Diarrhoea, Week 6
|
-0.61 units of a scale
Standard Deviation 19.93
|
3.48 units of a scale
Standard Deviation 23.93
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
Diarrhoea, Week 12
|
1.80 units of a scale
Standard Deviation 21.57
|
1.06 units of a scale
Standard Deviation 18.90
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of each treatment cycle up to 30 days after last dose (up to approximately 55 months) (Cycle length = 21 days)Population: ITT Population included all randomized participants irrespective of whether the assigned treatment was actually received. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
The EORTC QLQ-LC13 module incorporates one multiple item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. The EORTC QLQ-LC13 was scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however, a high score for a symptom scale or item represents a high level of symptomatology or problems. A≥10-point change in the symptoms subscale score was perceived by participants as clinically significant (Osoba et al. 1998). A positive change from baseline indicates improvement and negative change from baseline indicated worsening.
Outcome measures
| Measure |
Atezolizumab
n=302 Participants
Participants received atezolizumab 1200 mg, as IV infusion on Day 1 of each 21-day cycle until loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death.
|
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)
n=151 Participants
Participants received single agent chemotherapy; either vinorelbine oral or IV, or gemcitabine IV, according to the label based on investigator's choice until disease progression unacceptable toxicity, participant or physician decision to discontinue, or death.
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|---|---|---|
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Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dysphagia, Week 42
|
-7.55 units of a scale
Standard Deviation 31.11
|
4.76 units of a scale
Standard Deviation 17.82
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Arm or Shoulder, Week 24
|
-3.21 units of a scale
Standard Deviation 27.68
|
0.00 units of a scale
Standard Deviation 28.69
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Arm or Shoulder, Week 30
|
-0.40 units of a scale
Standard Deviation 26.80
|
4.55 units of a scale
Standard Deviation 25.81
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Arm or Shoulder, Week 36
|
-4.44 units of a scale
Standard Deviation 23.34
|
-2.22 units of a scale
Standard Deviation 34.43
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Arm or Shoulder, Week 48
|
-1.52 units of a scale
Standard Deviation 28.71
|
-6.06 units of a scale
Standard Deviation 35.96
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in other parts, Week 6
|
-1.85 units of a scale
Standard Deviation 29.05
|
1.18 units of a scale
Standard Deviation 33.31
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in other parts, Week 24
|
-3.53 units of a scale
Standard Deviation 35.35
|
-4.76 units of a scale
Standard Deviation 38.18
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in other parts, Week 66
|
3.45 units of a scale
Standard Deviation 37.10
|
-16.67 units of a scale
Standard Deviation 43.03
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in other parts, Week 84
|
-1.75 units of a scale
Standard Deviation 39.24
|
0.00 units of a scale
Standard Deviation 0.00
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in other parts, Week 111
|
-5.13 units of a scale
Standard Deviation 29.96
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in other parts, Week 165
|
-16.67 units of a scale
Standard Deviation 25.20
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in other parts, Week 183
|
8.33 units of a scale
Standard Deviation 63.10
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dyspnoea, Week 138
|
0.00 units of a scale
Standard Deviation 24.43
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dyspnoea, Week 147
|
-0.85 units of a scale
Standard Deviation 26.24
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Haemoptysis, Baseline
|
5.86 units of a scale
Standard Deviation 14.38
|
7.76 units of a scale
Standard Deviation 18.79
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Haemoptysis, Week 6
|
0.75 units of a scale
Standard Deviation 19.10
|
-4.64 units of a scale
Standard Deviation 21.58
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Haemoptysis, Week 12
|
-1.80 units of a scale
Standard Deviation 15.45
|
-3.17 units of a scale
Standard Deviation 20.49
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Haemoptysis, Week 18
|
-1.64 units of a scale
Standard Deviation 15.95
|
-1.71 units of a scale
Standard Deviation 17.01
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Haemoptysis, Week 24
|
-2.52 units of a scale
Standard Deviation 13.57
|
-1.11 units of a scale
Standard Deviation 18.54
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Haemoptysis, Week 30
|
-3.97 units of a scale
Standard Deviation 14.08
|
-2.90 units of a scale
Standard Deviation 13.90
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Haemoptysis, Week 36
|
-1.67 units of a scale
Standard Deviation 17.81
|
-6.25 units of a scale
Standard Deviation 18.13
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Haemoptysis, Week 42
|
-1.26 units of a scale
Standard Deviation 15.96
|
-2.38 units of a scale
Standard Deviation 20.52
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Haemoptysis, Week 48
|
-3.79 units of a scale
Standard Deviation 12.89
|
-5.56 units of a scale
Standard Deviation 19.25
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Haemoptysis, Week 57
|
-2.78 units of a scale
Standard Deviation 18.47
|
-8.33 units of a scale
Standard Deviation 23.57
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Haemoptysis, Week 66
|
-2.15 units of a scale
Standard Deviation 11.97
|
0.00 units of a scale
Standard Deviation 0.00
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Haemoptysis, Week 75
|
-1.33 units of a scale
Standard Deviation 11.71
|
0.00 units of a scale
Standard Deviation 0.00
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Haemoptysis, Week 84
|
-3.51 units of a scale
Standard Deviation 10.51
|
0.00 units of a scale
Standard Deviation 0.00
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Haemoptysis, Week 93
|
-1.67 units of a scale
Standard Deviation 13.13
|
0.00 units of a scale
Standard Deviation 0.00
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Haemoptysis, Week 102
|
-2.08 units of a scale
Standard Deviation 8.33
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Haemoptysis, Week 111
|
-2.38 units of a scale
Standard Deviation 8.91
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Haemoptysis, Week 120
|
-2.38 units of a scale
Standard Deviation 8.91
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Haemoptysis, Week 129
|
-2.38 units of a scale
Standard Deviation 8.91
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Haemoptysis, Week 138
|
-2.38 units of a scale
Standard Deviation 8.91
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Haemoptysis, Week 147
|
-2.38 units of a scale
Standard Deviation 8.91
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Haemoptysis, Week 156
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Haemoptysis, Week 165
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Haemoptysis, Week 174
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Haemoptysis, Week 183
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Haemoptysis, Week 192
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Haemoptysis, Week 201
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Haemoptysis, Week 210
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Haemoptysis, Safety Follow-Up Visit
|
3.03 units of a scale
Standard Deviation 17.98
|
-2.56 units of a scale
Standard Deviation 16.45
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Sore Mouth, Baseline
|
4.17 units of a scale
Standard Deviation 13.50
|
5.02 units of a scale
Standard Deviation 14.83
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Sore Mouth, Week 6
|
1.64 units of a scale
Standard Deviation 19.30
|
0.00 units of a scale
Standard Deviation 20.23
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Sore Mouth, Week 12
|
-0.22 units of a scale
Standard Deviation 17.91
|
0.00 units of a scale
Standard Deviation 16.80
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Sore Mouth, Week 18
|
-0.82 units of a scale
Standard Deviation 16.85
|
2.56 units of a scale
Standard Deviation 20.78
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Sore Mouth, Week 24
|
-1.90 units of a scale
Standard Deviation 19.52
|
2.30 units of a scale
Standard Deviation 17.66
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Sore Mouth, Week 30
|
-3.57 units of a scale
Standard Deviation 21.96
|
0.00 units of a scale
Standard Deviation 17.41
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Sore Mouth, Week 36
|
-2.73 units of a scale
Standard Deviation 22.19
|
-2.08 units of a scale
Standard Deviation 19.12
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Sore Mouth, Week 42
|
0.00 units of a scale
Standard Deviation 29.24
|
4.76 units of a scale
Standard Deviation 28.81
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Sore Mouth, Week 48
|
-5.30 units of a scale
Standard Deviation 18.94
|
-2.78 units of a scale
Standard Deviation 22.29
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Sore Mouth, Week 57
|
-5.56 units of a scale
Standard Deviation 20.31
|
0.00 units of a scale
Standard Deviation 17.82
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Sore Mouth, Week 66
|
-4.17 units of a scale
Standard Deviation 16.40
|
6.67 units of a scale
Standard Deviation 14.91
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Sore Mouth, Week 75
|
-5.33 units of a scale
Standard Deviation 15.75
|
16.67 units of a scale
Standard Deviation 19.25
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Sore Mouth, Week 84
|
-1.75 units of a scale
Standard Deviation 7.65
|
11.11 units of a scale
Standard Deviation 19.25
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Sore Mouth, Week 93
|
-1.67 units of a scale
Standard Deviation 7.45
|
0.00 units of a scale
Standard Deviation 0.00
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Sore Mouth, Week 102
|
2.08 units of a scale
Standard Deviation 8.33
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Sore Mouth, Week 111
|
0.00 units of a scale
Standard Deviation 22.65
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Sore Mouth, Week 120
|
2.38 units of a scale
Standard Deviation 8.91
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Sore Mouth, Week 129
|
-4.76 units of a scale
Standard Deviation 17.82
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Sore Mouth, Week 138
|
2.38 units of a scale
Standard Deviation 8.91
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Sore Mouth, Week 147
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Sore Mouth, Week 156
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Sore Mouth, Week 165
|
4.17 units of a scale
Standard Deviation 27.82
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Sore Mouth, Week 174
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Sore Mouth, Week 183
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Sore Mouth, Week 192
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Sore Mouth, Week 201
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Sore Mouth, Week 210
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Sore Mouth, Safety Follow-Up Visit
|
27.27 units of a scale
Standard Deviation 32.72
|
0.00 units of a scale
Standard Deviation 19.25
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dysphagia, Baseline
|
11.15 units of a scale
Standard Deviation 23.60
|
8.68 units of a scale
Standard Deviation 19.60
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dysphagia, Week 6
|
-1.20 units of a scale
Standard Deviation 20.47
|
2.90 units of a scale
Standard Deviation 25.96
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dysphagia, Week 12
|
-0.44 units of a scale
Standard Deviation 21.77
|
-1.04 units of a scale
Standard Deviation 23.73
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dysphagia, Week 18
|
-2.19 units of a scale
Standard Deviation 23.37
|
-0.85 units of a scale
Standard Deviation 29.11
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dysphagia, Week 24
|
-4.72 units of a scale
Standard Deviation 23.20
|
1.11 units of a scale
Standard Deviation 28.34
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dyspnoea, Baseline
|
34.30 units of a scale
Standard Deviation 25.69
|
36.67 units of a scale
Standard Deviation 25.35
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dyspnoea, Week 6
|
1.13 units of a scale
Standard Deviation 19.90
|
0.92 units of a scale
Standard Deviation 24.25
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dyspnoea, Week 12
|
-0.23 units of a scale
Standard Deviation 24.28
|
-2.87 units of a scale
Standard Deviation 24.55
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dyspnoea, Week 18
|
-4.78 units of a scale
Standard Deviation 18.93
|
0.90 units of a scale
Standard Deviation 23.33
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dyspnoea, Week 24
|
-5.05 units of a scale
Standard Deviation 22.91
|
2.68 units of a scale
Standard Deviation 23.13
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dyspnoea, Week 30
|
-5.34 units of a scale
Standard Deviation 22.00
|
1.52 units of a scale
Standard Deviation 25.03
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dyspnoea, Week 36
|
-3.90 units of a scale
Standard Deviation 26.85
|
5.56 units of a scale
Standard Deviation 19.85
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dyspnoea, Week 42
|
-11.11 units of a scale
Standard Deviation 26.63
|
-6.84 units of a scale
Standard Deviation 22.01
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dyspnoea, Week 48
|
-4.84 units of a scale
Standard Deviation 26.83
|
1.85 units of a scale
Standard Deviation 22.64
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dyspnoea, Week 57
|
-7.89 units of a scale
Standard Deviation 20.53
|
4.17 units of a scale
Standard Deviation 15.64
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dyspnoea, Week 66
|
-6.58 units of a scale
Standard Deviation 24.12
|
0.00 units of a scale
Standard Deviation 13.61
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dyspnoea, Week 75
|
-4.55 units of a scale
Standard Deviation 23.67
|
-2.78 units of a scale
Standard Deviation 30.60
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dyspnoea, Week 84
|
-8.50 units of a scale
Standard Deviation 23.74
|
3.70 units of a scale
Standard Deviation 23.13
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dyspnoea, Week 93
|
-2.34 units of a scale
Standard Deviation 27.61
|
5.56 units of a scale
Standard Deviation 7.86
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dyspnoea, Week 102
|
-2.96 units of a scale
Standard Deviation 21.19
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dyspnoea, Week 111
|
-2.56 units of a scale
Standard Deviation 26.51
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dyspnoea, Week 120
|
-4.27 units of a scale
Standard Deviation 24.23
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dyspnoea, Week 129
|
3.70 units of a scale
Standard Deviation 15.95
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dyspnoea, Week 156
|
1.59 units of a scale
Standard Deviation 14.95
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dyspnoea, Week 165
|
-1.85 units of a scale
Standard Deviation 21.56
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dyspnoea, Week 174
|
1.59 units of a scale
Standard Deviation 17.48
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dyspnoea, Week 183
|
5.56 units of a scale
Standard Deviation 21.28
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dyspnoea, Week 192
|
5.56 units of a scale
Standard Deviation 26.45
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dyspnoea, Week 201
|
0.00 units of a scale
Standard Deviation 15.71
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dyspnoea, Week 210
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dyspnoea, Safety Follow-Up Visit
|
12.12 units of a scale
Standard Deviation 29.17
|
6.48 units of a scale
Standard Deviation 31.94
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Coughing, Baseline
|
41.36 units of a scale
Standard Deviation 30.24
|
46.26 units of a scale
Standard Deviation 28.25
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Coughing, Week 6
|
-1.80 units of a scale
Standard Deviation 25.10
|
-5.46 units of a scale
Standard Deviation 29.80
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Coughing, Week 12
|
-7.61 units of a scale
Standard Deviation 30.79
|
-9.38 units of a scale
Standard Deviation 29.97
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Coughing, Week 18
|
-9.64 units of a scale
Standard Deviation 29.01
|
-3.42 units of a scale
Standard Deviation 34.87
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Coughing, Week 24
|
-11.01 units of a scale
Standard Deviation 30.42
|
3.33 units of a scale
Standard Deviation 30.76
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Coughing, Week 30
|
-9.24 units of a scale
Standard Deviation 33.46
|
0.00 units of a scale
Standard Deviation 26.01
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Coughing, Week 36
|
-7.10 units of a scale
Standard Deviation 35.02
|
0.00 units of a scale
Standard Deviation 34.43
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Coughing, Week 42
|
-10.06 units of a scale
Standard Deviation 31.07
|
-2.38 units of a scale
Standard Deviation 27.62
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Coughing, Week 48
|
-15.91 units of a scale
Standard Deviation 30.06
|
0.00 units of a scale
Standard Deviation 20.10
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Coughing, Week 57
|
-14.29 units of a scale
Standard Deviation 31.61
|
4.17 units of a scale
Standard Deviation 27.82
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Coughing, Week 66
|
-11.46 units of a scale
Standard Deviation 33.45
|
-13.33 units of a scale
Standard Deviation 18.26
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Coughing, Week 75
|
-9.33 units of a scale
Standard Deviation 28.09
|
-8.33 units of a scale
Standard Deviation 16.67
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Coughing, Week 84
|
-19.30 units of a scale
Standard Deviation 32.04
|
11.11 units of a scale
Standard Deviation 19.25
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Coughing, Week 93
|
-21.67 units of a scale
Standard Deviation 31.11
|
16.67 units of a scale
Standard Deviation 23.57
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Coughing, Week 102
|
-14.58 units of a scale
Standard Deviation 20.97
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Coughing, Week 111
|
-11.90 units of a scale
Standard Deviation 21.11
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Coughing, Week 120
|
-11.90 units of a scale
Standard Deviation 21.11
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Coughing, Week 129
|
-14.29 units of a scale
Standard Deviation 21.54
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Coughing, Week 138
|
-16.67 units of a scale
Standard Deviation 21.68
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Coughing, Week 147
|
-21.43 units of a scale
Standard Deviation 24.83
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Coughing, Week 156
|
-23.81 units of a scale
Standard Deviation 31.71
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Coughing, Week 165
|
-16.67 units of a scale
Standard Deviation 35.63
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Coughing, Week 174
|
-19.05 units of a scale
Standard Deviation 32.53
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Coughing, Week 183
|
0.00 units of a scale
Standard Deviation 27.22
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Coughing, Week 192
|
-16.67 units of a scale
Standard Deviation 19.25
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Coughing, Week 201
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Coughing, Week 210
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Coughing, Safety Follow-Up Visit
|
3.03 units of a scale
Standard Deviation 37.87
|
-17.95 units of a scale
Standard Deviation 25.88
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Alopecia, Week 93
|
5.00 units of a scale
Standard Deviation 12.21
|
16.67 units of a scale
Standard Deviation 23.57
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Alopecia, Week 102
|
4.17 units of a scale
Standard Deviation 11.39
|
33.33 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Alopecia, Week 111
|
2.38 units of a scale
Standard Deviation 8.91
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Alopecia, Week 120
|
4.76 units of a scale
Standard Deviation 12.10
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Alopecia, Week 129
|
2.38 units of a scale
Standard Deviation 8.91
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Alopecia, Week 138
|
7.14 units of a scale
Standard Deviation 19.30
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Alopecia, Week 147
|
2.38 units of a scale
Standard Deviation 8.91
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Alopecia, Week 156
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Alopecia, Week 165
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Alopecia, Week 174
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Alopecia, Week 183
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Alopecia, Week 192
|
8.33 units of a scale
Standard Deviation 16.67
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Alopecia, Week 201
|
16.67 units of a scale
Standard Deviation 23.57
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Alopecia, Week 210
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Alopecia, Safety Follow-Up Visit
|
0.00 units of a scale
Standard Deviation 0.00
|
12.82 units of a scale
Standard Deviation 44.18
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Chest, Baseline
|
20.29 units of a scale
Standard Deviation 26.70
|
19.91 units of a scale
Standard Deviation 24.72
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Chest, Week 6
|
-2.45 units of a scale
Standard Deviation 26.66
|
-4.09 units of a scale
Standard Deviation 29.79
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Chest, Week 12
|
-4.03 units of a scale
Standard Deviation 27.65
|
-5.29 units of a scale
Standard Deviation 31.80
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Chest, Week 18
|
-9.37 units of a scale
Standard Deviation 27.29
|
-5.26 units of a scale
Standard Deviation 26.31
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Chest, Week 24
|
-7.62 units of a scale
Standard Deviation 28.22
|
-2.30 units of a scale
Standard Deviation 28.07
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Chest, Week 30
|
-7.23 units of a scale
Standard Deviation 31.26
|
-9.09 units of a scale
Standard Deviation 34.40
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Chest, Week 36
|
-11.67 units of a scale
Standard Deviation 29.96
|
2.38 units of a scale
Standard Deviation 30.56
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Chest, Week 42
|
-11.54 units of a scale
Standard Deviation 34.86
|
-2.56 units of a scale
Standard Deviation 31.80
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Chest, Week 48
|
-17.83 units of a scale
Standard Deviation 28.50
|
3.03 units of a scale
Standard Deviation 17.98
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Chest, Week 57
|
-18.10 units of a scale
Standard Deviation 30.62
|
-4.76 units of a scale
Standard Deviation 23.00
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Chest, Week 66
|
-15.05 units of a scale
Standard Deviation 34.25
|
-16.67 units of a scale
Standard Deviation 19.25
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Chest, Week 75
|
-13.89 units of a scale
Standard Deviation 21.80
|
-22.22 units of a scale
Standard Deviation 19.25
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Chest, Week 84
|
-22.81 units of a scale
Standard Deviation 31.53
|
-16.67 units of a scale
Standard Deviation 23.57
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Chest, Week 93
|
-23.33 units of a scale
Standard Deviation 26.71
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Chest, Week 102
|
-20.83 units of a scale
Standard Deviation 31.91
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Chest, Week 111
|
-26.19 units of a scale
Standard Deviation 29.75
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Chest, Week 120
|
-26.19 units of a scale
Standard Deviation 29.75
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Chest, Week 129
|
-21.43 units of a scale
Standard Deviation 21.11
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Chest, Week 138
|
-26.19 units of a scale
Standard Deviation 29.75
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Chest, Week 147
|
-19.05 units of a scale
Standard Deviation 36.31
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Chest, Week 156
|
-23.81 units of a scale
Standard Deviation 25.20
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Chest, Week 165
|
-25.00 units of a scale
Standard Deviation 23.57
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Chest, Week 174
|
-23.81 units of a scale
Standard Deviation 25.20
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Chest, Week 183
|
-16.67 units of a scale
Standard Deviation 33.33
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Chest, Week 192
|
-16.67 units of a scale
Standard Deviation 33.33
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Chest, Week 201
|
-33.33 units of a scale
Standard Deviation 47.14
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Chest, Week 210
|
-66.67 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Chest, Safety Follow-Up Visit
|
0.00 units of a scale
Standard Deviation 21.08
|
12.82 units of a scale
Standard Deviation 21.68
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Arm or Shoulder, Baseline
|
19.16 units of a scale
Standard Deviation 28.08
|
19.08 units of a scale
Standard Deviation 27.43
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Arm or Shoulder, Week 6
|
-0.45 units of a scale
Standard Deviation 26.87
|
-0.58 units of a scale
Standard Deviation 29.07
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Arm or Shoulder, Week 12
|
0.67 units of a scale
Standard Deviation 29.38
|
-4.23 units of a scale
Standard Deviation 30.81
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Arm or Shoulder, Week 18
|
-1.65 units of a scale
Standard Deviation 30.08
|
-2.63 units of a scale
Standard Deviation 34.99
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Arm or Shoulder, Week 42
|
-1.89 units of a scale
Standard Deviation 25.67
|
-5.13 units of a scale
Standard Deviation 38.12
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Arm or Shoulder, Week 57
|
7.41 units of a scale
Standard Deviation 25.34
|
-9.52 units of a scale
Standard Deviation 37.09
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Arm or Shoulder, Week 66
|
1.08 units of a scale
Standard Deviation 26.50
|
-33.33 units of a scale
Standard Deviation 38.49
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Arm or Shoulder, Week 75
|
-1.39 units of a scale
Standard Deviation 26.88
|
-33.33 units of a scale
Standard Deviation 33.33
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Arm or Shoulder, Week 84
|
3.51 units of a scale
Standard Deviation 24.58
|
-16.67 units of a scale
Standard Deviation 23.57
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Arm or Shoulder, Week 93
|
6.67 units of a scale
Standard Deviation 23.20
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Arm or Shoulder, Week 102
|
8.33 units of a scale
Standard Deviation 25.82
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Arm or Shoulder, Week 111
|
2.38 units of a scale
Standard Deviation 27.62
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Arm or Shoulder, Week 120
|
4.76 units of a scale
Standard Deviation 25.68
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Arm or Shoulder, Week 129
|
2.38 units of a scale
Standard Deviation 27.62
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Arm or Shoulder, Week 138
|
2.38 units of a scale
Standard Deviation 24.33
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Arm or Shoulder, Week 147
|
2.38 units of a scale
Standard Deviation 27.62
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Arm or Shoulder, Week 156
|
9.52 units of a scale
Standard Deviation 16.27
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Arm or Shoulder, Week 165
|
4.17 units of a scale
Standard Deviation 11.79
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Arm or Shoulder, Week 174
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Arm or Shoulder, Week 183
|
25.00 units of a scale
Standard Deviation 31.91
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Arm or Shoulder, Week 192
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Arm or Shoulder, Week 201
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Arm or Shoulder, Week 210
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in Arm or Shoulder, Safety Follow-Up Visit
|
12.12 units of a scale
Standard Deviation 42.88
|
7.69 units of a scale
Standard Deviation 33.76
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in other parts, Baseline
|
25.32 units of a scale
Standard Deviation 31.93
|
27.55 units of a scale
Standard Deviation 31.86
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in other parts, Week 12
|
-0.91 units of a scale
Standard Deviation 32.63
|
-0.54 units of a scale
Standard Deviation 34.93
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in other parts, Week 18
|
-1.74 units of a scale
Standard Deviation 36.63
|
11.11 units of a scale
Standard Deviation 36.51
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in other parts, Week 30
|
-2.88 units of a scale
Standard Deviation 38.08
|
-7.58 units of a scale
Standard Deviation 20.40
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in other parts, Week 36
|
-5.08 units of a scale
Standard Deviation 33.23
|
2.22 units of a scale
Standard Deviation 29.46
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in other parts, Week 42
|
-2.67 units of a scale
Standard Deviation 33.56
|
-12.82 units of a scale
Standard Deviation 32.03
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in other parts, Week 48
|
-4.65 units of a scale
Standard Deviation 27.78
|
-15.15 units of a scale
Standard Deviation 34.52
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in other parts, Week 57
|
-1.96 units of a scale
Standard Deviation 34.76
|
-9.52 units of a scale
Standard Deviation 31.71
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in other parts, Week 75
|
8.33 units of a scale
Standard Deviation 31.47
|
0.00 units of a scale
Standard Deviation 0.00
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in other parts, Week 93
|
-3.33 units of a scale
Standard Deviation 28.41
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in other parts, Week 102
|
-4.17 units of a scale
Standard Deviation 26.87
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in other parts, Week 120
|
0.00 units of a scale
Standard Deviation 26.15
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in other parts, Week 129
|
-7.14 units of a scale
Standard Deviation 14.19
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in other parts, Week 138
|
-7.14 units of a scale
Standard Deviation 19.30
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in other parts, Week 147
|
0.00 units of a scale
Standard Deviation 18.49
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in other parts, Week 156
|
-14.29 units of a scale
Standard Deviation 26.23
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in other parts, Week 174
|
-9.52 units of a scale
Standard Deviation 31.71
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in other parts, Week 192
|
-8.33 units of a scale
Standard Deviation 31.91
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in other parts, Week 201
|
-33.33 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in other parts, Week 210
|
-66.67 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Pain in other parts, Safety Follow-Up Visit
|
9.09 units of a scale
Standard Deviation 42.40
|
0.00 units of a scale
Standard Deviation 33.33
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dysphagia, Week 30
|
-3.57 units of a scale
Standard Deviation 23.15
|
2.90 units of a scale
Standard Deviation 28.27
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dysphagia, Week 36
|
-6.11 units of a scale
Standard Deviation 28.45
|
6.25 units of a scale
Standard Deviation 13.44
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dysphagia, Week 48
|
-5.30 units of a scale
Standard Deviation 23.78
|
0.00 units of a scale
Standard Deviation 14.21
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dysphagia, Week 57
|
-3.70 units of a scale
Standard Deviation 29.58
|
4.17 units of a scale
Standard Deviation 21.36
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dysphagia, Week 66
|
-6.45 units of a scale
Standard Deviation 32.68
|
0.00 units of a scale
Standard Deviation 0.00
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dysphagia, Week 75
|
-4.00 units of a scale
Standard Deviation 27.76
|
16.67 units of a scale
Standard Deviation 33.33
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dysphagia, Week 84
|
-8.77 units of a scale
Standard Deviation 33.04
|
0.00 units of a scale
Standard Deviation 0.00
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dysphagia, Week 93
|
0.00 units of a scale
Standard Deviation 28.61
|
0.00 units of a scale
Standard Deviation 0.00
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dysphagia, Week 102
|
0.00 units of a scale
Standard Deviation 0.00
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dysphagia, Week 111
|
-4.76 units of a scale
Standard Deviation 22.10
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dysphagia, Week 120
|
2.38 units of a scale
Standard Deviation 8.91
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dysphagia, Week 129
|
-2.38 units of a scale
Standard Deviation 20.52
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dysphagia, Week 138
|
4.76 units of a scale
Standard Deviation 12.10
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dysphagia, Week 147
|
-4.76 units of a scale
Standard Deviation 28.81
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dysphagia, Week 156
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dysphagia, Week 165
|
-8.33 units of a scale
Standard Deviation 23.57
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dysphagia, Week 174
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dysphagia, Week 183
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dysphagia, Week 192
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dysphagia, Week 201
|
16.67 units of a scale
Standard Deviation 23.57
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dysphagia, Week 210
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Dysphagia, Safety Follow-Up Visit
|
12.12 units of a scale
Standard Deviation 37.34
|
0.00 units of a scale
Standard Deviation 19.25
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Peripheral Neuropathy, Baseline
|
11.26 units of a scale
Standard Deviation 21.10
|
14.84 units of a scale
Standard Deviation 24.46
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Peripheral Neuropathy, Week 6
|
3.29 units of a scale
Standard Deviation 19.74
|
1.45 units of a scale
Standard Deviation 25.51
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Peripheral Neuropathy, Week 12
|
1.99 units of a scale
Standard Deviation 21.16
|
2.08 units of a scale
Standard Deviation 26.48
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Peripheral Neuropathy, Week 18
|
1.10 units of a scale
Standard Deviation 19.21
|
5.13 units of a scale
Standard Deviation 24.83
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Peripheral Neuropathy, Week 24
|
3.77 units of a scale
Standard Deviation 23.60
|
7.78 units of a scale
Standard Deviation 22.63
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Peripheral Neuropathy, Week 30
|
4.82 units of a scale
Standard Deviation 20.25
|
-1.45 units of a scale
Standard Deviation 21.27
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Peripheral Neuropathy, Week 36
|
7.78 units of a scale
Standard Deviation 24.83
|
12.50 units of a scale
Standard Deviation 29.50
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Peripheral Neuropathy, Week 42
|
8.18 units of a scale
Standard Deviation 23.48
|
9.52 units of a scale
Standard Deviation 20.37
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Peripheral Neuropathy, Week 48
|
6.82 units of a scale
Standard Deviation 23.38
|
8.33 units of a scale
Standard Deviation 20.72
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Peripheral Neuropathy, Week 57
|
7.41 units of a scale
Standard Deviation 25.34
|
20.83 units of a scale
Standard Deviation 30.54
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Peripheral Neuropathy, Week 66
|
6.25 units of a scale
Standard Deviation 23.09
|
13.33 units of a scale
Standard Deviation 38.01
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Peripheral Neuropathy, Week 75
|
5.33 units of a scale
Standard Deviation 22.93
|
8.33 units of a scale
Standard Deviation 31.91
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Peripheral Neuropathy, Week 84
|
8.77 units of a scale
Standard Deviation 21.78
|
0.00 units of a scale
Standard Deviation 0.00
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Peripheral Neuropathy, Week 93
|
6.67 units of a scale
Standard Deviation 17.44
|
0.00 units of a scale
Standard Deviation 0.00
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Peripheral Neuropathy, Week 102
|
6.25 units of a scale
Standard Deviation 18.13
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Peripheral Neuropathy, Week 111
|
2.38 units of a scale
Standard Deviation 15.82
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Peripheral Neuropathy, Week 120
|
2.38 units of a scale
Standard Deviation 15.82
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Peripheral Neuropathy, Week 129
|
2.38 units of a scale
Standard Deviation 15.82
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Peripheral Neuropathy, Week 138
|
0.00 units of a scale
Standard Deviation 13.07
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Peripheral Neuropathy, Week 147
|
2.38 units of a scale
Standard Deviation 15.82
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Peripheral Neuropathy, Week 156
|
-4.76 units of a scale
Standard Deviation 12.60
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Peripheral Neuropathy, Week 165
|
0.00 units of a scale
Standard Deviation 17.82
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Peripheral Neuropathy, Week 174
|
-4.76 units of a scale
Standard Deviation 12.60
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Peripheral Neuropathy, Week 183
|
-8.33 units of a scale
Standard Deviation 16.67
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Peripheral Neuropathy, Week 192
|
16.67 units of a scale
Standard Deviation 43.03
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Peripheral Neuropathy, Week 201
|
0.00 units of a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Peripheral Neuropathy, Week 210
|
0.00 units of a scale
Standard Deviation NA
The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so standard deviation is not available.
|
—
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Peripheral Neuropathy, Safety Follow-Up Visit
|
21.21 units of a scale
Standard Deviation 40.20
|
-2.78 units of a scale
Standard Deviation 33.21
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Alopecia, Baseline
|
7.91 units of a scale
Standard Deviation 20.70
|
4.83 units of a scale
Standard Deviation 15.70
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Alopecia, Week 6
|
-1.06 units of a scale
Standard Deviation 19.48
|
6.09 units of a scale
Standard Deviation 27.07
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Alopecia, Week 12
|
-2.01 units of a scale
Standard Deviation 17.43
|
7.94 units of a scale
Standard Deviation 27.90
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Alopecia, Week 18
|
-1.93 units of a scale
Standard Deviation 17.90
|
12.82 units of a scale
Standard Deviation 23.71
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Alopecia, Week 24
|
-1.27 units of a scale
Standard Deviation 17.86
|
14.29 units of a scale
Standard Deviation 30.67
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Alopecia, Week 30
|
-1.20 units of a scale
Standard Deviation 19.79
|
10.14 units of a scale
Standard Deviation 27.40
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Alopecia, Week 36
|
5.56 units of a scale
Standard Deviation 17.54
|
10.42 units of a scale
Standard Deviation 29.11
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Alopecia, Week 42
|
3.85 units of a scale
Standard Deviation 14.24
|
7.14 units of a scale
Standard Deviation 29.75
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Alopecia, Week 48
|
3.10 units of a scale
Standard Deviation 17.54
|
13.89 units of a scale
Standard Deviation 36.12
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Alopecia, Week 57
|
7.62 units of a scale
Standard Deviation 18.23
|
29.17 units of a scale
Standard Deviation 27.82
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Alopecia, Week 66
|
6.67 units of a scale
Standard Deviation 13.56
|
6.67 units of a scale
Standard Deviation 14.91
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Alopecia, Week 75
|
5.56 units of a scale
Standard Deviation 12.69
|
8.33 units of a scale
Standard Deviation 16.67
|
|
Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Alopecia, Week 84
|
1.75 units of a scale
Standard Deviation 7.65
|
11.11 units of a scale
Standard Deviation 19.25
|
SECONDARY outcome
Timeframe: From baseline up to approximately 55 monthsPopulation: ITT population included all randomized participants irrespective of whether the assigned treatment was actually received.
TTD with use of the EORTC was defined as the time from randomization to the first confirmed clinically meaningful deterioration in EORTC symptom scores. Confirmed clinically meaningful deterioration in lung cancer symptoms was defined as a = 10-point increase above baseline in a symptom score that must be held for at least two consecutive assessments or an initial = 10-point increase above baseline followed by either (a) death within 6 weeks from the last assessment through Week 48 or (b) death within 9 weeks from the last assessment from Week 48 thereafter. A = 10-point change in the EORTC scale score was perceived by participants as clinically significant (Osoba et al. 1998).
Outcome measures
| Measure |
Atezolizumab
n=302 Participants
Participants received atezolizumab 1200 mg, as IV infusion on Day 1 of each 21-day cycle until loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death.
|
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)
n=151 Participants
Participants received single agent chemotherapy; either vinorelbine oral or IV, or gemcitabine IV, according to the label based on investigator's choice until disease progression unacceptable toxicity, participant or physician decision to discontinue, or death.
|
|---|---|---|
|
Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC QLQ-C30 Score
Dyspnoea
|
NA Months
Interval 19.0 to
Median and/or CI are not estimable due to insufficient number of patients with events.
|
NA Months
Interval 8.3 to
Median and/or CI are not estimable due to insufficient number of patients with events.
|
|
Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC QLQ-C30 Score
Fatigue
|
13.5 Months
Interval 8.3 to
Median and/or CI are not estimable due to insufficient number of patients with events.
|
8.4 Months
Interval 5.6 to
Median and/or CI are not estimable due to insufficient number of patients with events.
|
SECONDARY outcome
Timeframe: From baseline up to approximately 55 monthsPopulation: ITT population included all randomized participants irrespective of whether the assigned treatment was actually received.
TTD with use of the EORTC was defined as the time from randomization to the first confirmed clinically meaningful deterioration in EORTC symptom scores. Confirmed clinically meaningful deterioration in lung cancer symptoms was defined as a = 10-point increase above baseline in a symptom score that must be held for at least two consecutive assessments or an initial = 10-point increase above baseline followed by either (a) death within 6 weeks from the last assessment through Week 48 or (b) death within 9 weeks from the last assessment from Week 48 thereafter. A = 10-point change in the EORTC scale score was perceived by participants as clinically significant.
Outcome measures
| Measure |
Atezolizumab
n=302 Participants
Participants received atezolizumab 1200 mg, as IV infusion on Day 1 of each 21-day cycle until loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death.
|
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)
n=151 Participants
Participants received single agent chemotherapy; either vinorelbine oral or IV, or gemcitabine IV, according to the label based on investigator's choice until disease progression unacceptable toxicity, participant or physician decision to discontinue, or death.
|
|---|---|---|
|
TTD in Patient-Reported Lung Cancer Symptoms As Assessed by EORTC QLQ-LC13 Score
Cough
|
NA Months
Median and/or CI are not estimable due to insufficient number of patients with events.
|
21.4 Months
Interval 13.9 to
Median and/or CI are not estimable due to insufficient number of patients with events.
|
|
TTD in Patient-Reported Lung Cancer Symptoms As Assessed by EORTC QLQ-LC13 Score
Chest Pain
|
NA Months
Median and/or CI are not estimable due to insufficient number of patients with events.
|
NA Months
Interval 6.8 to
Median and/or CI are not estimable due to insufficient number of patients with events.
|
|
TTD in Patient-Reported Lung Cancer Symptoms As Assessed by EORTC QLQ-LC13 Score
Dyspnoea
|
17.3 Months
Interval 9.6 to 34.2
|
8.3 Months
Interval 5.5 to
Median and/or CI are not estimable due to insufficient number of patients with events.
|
|
TTD in Patient-Reported Lung Cancer Symptoms As Assessed by EORTC QLQ-LC13 Score
Arm and/or Shoulder Pain
|
21.3 Months
Interval 13.6 to
Median and/or CI are not estimable due to insufficient number of patients with events.
|
13.9 Months
Interval 8.6 to
Median and/or CI are not estimable due to insufficient number of patients with events.
|
|
TTD in Patient-Reported Lung Cancer Symptoms As Assessed by EORTC QLQ-LC13 Score
Composite of Cough, Dyspnea and Chest Pain
|
8.3 Months
Interval 5.5 to 17.3
|
4.2 Months
Interval 2.9 to 5.6
|
SECONDARY outcome
Timeframe: From randomization up to death from any cause (up to approximately 55 months)Population: ITT Population included all randomized participants irrespective of whether the assigned treatment was actually received. Overall number analyzed is the number of participants with data available for analysis.
OS was defined as the time between the date of randomization and the date of death due to any cause. OS was assessed in participants whose tumors express PD-L1 protein (i.e., tumor cell (TC) ≥1%) as measured by PD-L1 SP263 immunohistochemistry (IHC) assay. KM estimates were used to calculate the median.
Outcome measures
| Measure |
Atezolizumab
n=127 Participants
Participants received atezolizumab 1200 mg, as IV infusion on Day 1 of each 21-day cycle until loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death.
|
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)
n=78 Participants
Participants received single agent chemotherapy; either vinorelbine oral or IV, or gemcitabine IV, according to the label based on investigator's choice until disease progression unacceptable toxicity, participant or physician decision to discontinue, or death.
|
|---|---|---|
|
OS in Participants With Programmed Death-Ligand 1 (PD-L1) Positive Status
|
9.4 Months
Interval 7.0 to 11.3
|
10.3 Months
Interval 7.1 to 12.3
|
SECONDARY outcome
Timeframe: From randomization to the first occurence of disease progression or death from any cause, whichever occurs first (up to approximately 55 months)Population: ITT Population included all randomized participants irrespective of whether the assigned treatment was actually received. Overall number analyzed is the number of participants with data available for analysis.
PFS was defined as the time from randomization to the first documented disease progression as determined by the investigator with the use of RECIST v1.1 or death from any cause, whichever occurs first. PD was defined as at least 20% increase in the sum of diameters of lesions, taking as reference the smallest sum during the study (nadir), including baseline. Investigator-assessed PFS was assessed in participants whose tumors express PD-L1 protein as measured by PD-L1 SP263 IHC assay. KM estimates were used to calculate the median.
Outcome measures
| Measure |
Atezolizumab
n=127 Participants
Participants received atezolizumab 1200 mg, as IV infusion on Day 1 of each 21-day cycle until loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death.
|
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)
n=78 Participants
Participants received single agent chemotherapy; either vinorelbine oral or IV, or gemcitabine IV, according to the label based on investigator's choice until disease progression unacceptable toxicity, participant or physician decision to discontinue, or death.
|
|---|---|---|
|
PFS as Determined by the Investigator Using RECIST v1.1 in Participants With PD-L1 Positive Status
|
4.2 Months
Interval 2.9 to 5.8
|
3.0 Months
Interval 2.8 to 5.4
|
Adverse Events
Atezolizumab
Serious events: 147 serious events
Other events: 234 other events
Deaths: 248 deaths
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)
Serious events: 54 serious events
Other events: 128 other events
Deaths: 129 deaths
Serious adverse events
| Measure |
Atezolizumab
n=300 participants at risk
Participants received atezolizumab 1200 mg, as IV infusion on Day 1 of each 21-day cycle until loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death.
|
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)
n=147 participants at risk
Participants received single agent chemotherapy; either vinorelbine oral or IV, or gemcitabine IV, according to the label based on investigator's choice until disease progression unacceptable toxicity, participant or physician decision to discontinue, or death.
|
|---|---|---|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/300 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.68%
1/147 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/300 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
2.0%
3/147 • Number of events 3 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.67%
2/300 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.68%
1/147 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.00%
0/300 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
1.4%
2/147 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/300 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.68%
1/147 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
1.4%
2/147 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.67%
2/300 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
1.0%
3/300 • Number of events 3 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.68%
1/147 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Cardiac disorders
Cardiac disorder
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Cardiac disorders
Cardiac failure
|
1.0%
3/300 • Number of events 3 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Cardiac disorders
Myocarditis
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/300 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.68%
1/147 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.33%
1/300 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/300 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.68%
1/147 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
General disorders
Asthenia
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
General disorders
Chest pain
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
General disorders
Death
|
2.3%
7/300 • Number of events 7 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
1.4%
2/147 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
General disorders
General physical health deterioration
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.68%
1/147 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
General disorders
Generalised oedema
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/300 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.68%
1/147 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
General disorders
Malaise
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
General disorders
Oedema
|
0.00%
0/300 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.68%
1/147 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
General disorders
Performance status decreased
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
General disorders
Pyrexia
|
1.0%
3/300 • Number of events 3 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.68%
1/147 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
General disorders
Sudden cardiac death
|
0.67%
2/300 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Hepatobiliary disorders
Cholangitis
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Hepatobiliary disorders
Hepatitis
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.67%
2/300 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Hepatobiliary disorders
Liver injury
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Immune system disorders
Systemic immune activation
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/300 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.68%
1/147 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Infections and infestations
Brain abscess
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Infections and infestations
Bronchitis
|
0.67%
2/300 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.68%
1/147 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Infections and infestations
COVID-19
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Infections and infestations
Cellulitis
|
0.67%
2/300 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Infections and infestations
Diarrhoea infectious
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/300 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.68%
1/147 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/300 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.68%
1/147 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Infections and infestations
Infectious pleural effusion
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
1.7%
5/300 • Number of events 5 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Infections and infestations
Influenza
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.7%
5/300 • Number of events 5 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
2.7%
4/147 • Number of events 5 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/300 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
1.4%
2/147 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Infections and infestations
Pneumonia
|
11.3%
34/300 • Number of events 38 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
7.5%
11/147 • Number of events 13 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Infections and infestations
Pneumonia aspiration
|
0.67%
2/300 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Infections and infestations
Pneumonia bacterial
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Infections and infestations
Pneumonia fungal
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Infections and infestations
Relapsing fever
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.67%
2/300 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.68%
1/147 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/300 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
2.7%
4/147 • Number of events 4 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Infections and infestations
Septic shock
|
0.67%
2/300 • Number of events 3 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Infections and infestations
Skin infection
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.0%
3/300 • Number of events 3 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.67%
2/300 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.68%
1/147 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.67%
2/300 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.67%
2/300 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Investigations
Eastern Cooperative Oncology Group performance status worsened
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.67%
2/300 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.67%
2/300 • Number of events 3 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.0%
3/300 • Number of events 7 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.67%
2/300 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Nervous system disorders
Cerebral infarction
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
1.4%
2/147 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/300 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.68%
1/147 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Nervous system disorders
Lacunar infarction
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Nervous system disorders
Lacunar stroke
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Nervous system disorders
Myasthenia gravis
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Nervous system disorders
Seizure
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/300 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.68%
1/147 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Nervous system disorders
Syncope
|
0.67%
2/300 • Number of events 4 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.68%
1/147 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Psychiatric disorders
Confusional state
|
0.67%
2/300 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Psychiatric disorders
Disorientation
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.0%
3/300 • Number of events 3 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
1.4%
2/147 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.68%
1/147 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.33%
1/300 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.3%
7/300 • Number of events 7 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
1.4%
2/147 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
6/300 • Number of events 6 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
1.4%
2/147 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
1.4%
2/147 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/300 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.68%
1/147 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.0%
9/300 • Number of events 10 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
1.4%
2/147 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.7%
8/300 • Number of events 9 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
1.4%
2/147 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.0%
3/300 • Number of events 4 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.0%
3/300 • Number of events 3 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
2.0%
3/147 • Number of events 3 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.67%
2/300 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.68%
1/147 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/300 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.68%
1/147 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.67%
2/300 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/300 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.68%
1/147 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Vascular disorders
Superior vena cava occlusion
|
0.00%
0/300 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.68%
1/147 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/300 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.68%
1/147 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/300 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.68%
1/147 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Infections and infestations
Klebsiella urinary tract infection
|
0.00%
0/300 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.68%
1/147 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Vascular disorders
Iliac artery dissection
|
0.33%
1/300 • Number of events 1 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
Other adverse events
| Measure |
Atezolizumab
n=300 participants at risk
Participants received atezolizumab 1200 mg, as IV infusion on Day 1 of each 21-day cycle until loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death.
|
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)
n=147 participants at risk
Participants received single agent chemotherapy; either vinorelbine oral or IV, or gemcitabine IV, according to the label based on investigator's choice until disease progression unacceptable toxicity, participant or physician decision to discontinue, or death.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
16.0%
48/300 • Number of events 61 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
19.0%
28/147 • Number of events 31 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
40/300 • Number of events 57 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
16.3%
24/147 • Number of events 45 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Nausea
|
10.7%
32/300 • Number of events 40 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
24.5%
36/147 • Number of events 54 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
50/300 • Number of events 57 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
32.7%
48/147 • Number of events 70 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.0%
3/300 • Number of events 3 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
7.5%
11/147 • Number of events 15 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.67%
2/300 • Number of events 3 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
12.2%
18/147 • Number of events 39 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Endocrine disorders
Hypothyroidism
|
6.3%
19/300 • Number of events 22 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
0.00%
0/147 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
25/300 • Number of events 33 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
15.6%
23/147 • Number of events 42 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
General disorders
Asthenia
|
14.3%
43/300 • Number of events 49 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
12.9%
19/147 • Number of events 25 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
General disorders
Fatigue
|
19.3%
58/300 • Number of events 74 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
23.1%
34/147 • Number of events 34 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
General disorders
Oedema peripheral
|
8.3%
25/300 • Number of events 28 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
4.1%
6/147 • Number of events 6 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
General disorders
Pyrexia
|
10.0%
30/300 • Number of events 35 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
6.8%
10/147 • Number of events 18 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Infections and infestations
Pneumonia
|
5.0%
15/300 • Number of events 15 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
3.4%
5/147 • Number of events 6 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Infections and infestations
Urinary tract infection
|
9.7%
29/300 • Number of events 47 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
8.2%
12/147 • Number of events 15 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Investigations
Blood creatinine increased
|
5.0%
15/300 • Number of events 26 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
2.7%
4/147 • Number of events 5 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Investigations
Neutrophil count decreased
|
0.67%
2/300 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
11.6%
17/147 • Number of events 26 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Investigations
Weight decreased
|
7.3%
22/300 • Number of events 30 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
7.5%
11/147 • Number of events 13 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Investigations
White blood cell count decreased
|
0.67%
2/300 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
10.2%
15/147 • Number of events 26 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.0%
66/300 • Number of events 75 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
21.8%
32/147 • Number of events 40 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.0%
18/300 • Number of events 28 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
1.4%
2/147 • Number of events 2 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.3%
25/300 • Number of events 28 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
4.8%
7/147 • Number of events 7 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.3%
28/300 • Number of events 36 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
8.2%
12/147 • Number of events 15 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
25/300 • Number of events 29 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
8.8%
13/147 • Number of events 14 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.0%
12/300 • Number of events 12 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
5.4%
8/147 • Number of events 9 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Nervous system disorders
Dizziness
|
4.7%
14/300 • Number of events 18 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
5.4%
8/147 • Number of events 10 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Nervous system disorders
Headache
|
5.0%
15/300 • Number of events 20 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
4.8%
7/147 • Number of events 7 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Psychiatric disorders
Insomnia
|
5.7%
17/300 • Number of events 18 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
3.4%
5/147 • Number of events 5 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.7%
59/300 • Number of events 72 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
8.8%
13/147 • Number of events 14 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.7%
56/300 • Number of events 60 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
9.5%
14/147 • Number of events 15 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.3%
19/300 • Number of events 26 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
6.1%
9/147 • Number of events 10 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
23/300 • Number of events 34 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
2.0%
3/147 • Number of events 3 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
30/300 • Number of events 44 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
3.4%
5/147 • Number of events 7 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
|
Vascular disorders
Hypertension
|
7.7%
23/300 • Number of events 39 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
4.1%
6/147 • Number of events 8 • From Day 1 up to 90 days after last atezolizumab dose (up to approximately 62 months)
Safety population included participants who received any amount of any study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER