Trial Outcomes & Findings for A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy (NCT NCT02008227)
NCT ID: NCT02008227
Last Updated: 2019-12-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1225 participants
Primary outcome timeframe
Baseline until death due to any cause (up to approximately 2.25 years)
Results posted on
2019-12-20
Participant Flow
Twelve hundred and twenty-five participants were randomized in the study and were considered the Secondary Population (SP), out of which first 850 randomized participants were considered the Primary Population (PP).
Participant milestones
| Measure |
Docetaxel
Docetaxel 75 milligrams per square meter (mg/m\^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
Atezolizumab 1200 milligrams (mg) was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
Overall Study
STARTED
|
612
|
613
|
|
Overall Study
Treated
|
579
|
608
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
612
|
613
|
Reasons for withdrawal
| Measure |
Docetaxel
Docetaxel 75 milligrams per square meter (mg/m\^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
Atezolizumab 1200 milligrams (mg) was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
9
|
|
Overall Study
Death
|
494
|
485
|
|
Overall Study
Withdrawal by Subject
|
67
|
36
|
|
Overall Study
Study Terminated By Sponsor
|
44
|
83
|
Baseline Characteristics
SP-ITT Population
Baseline characteristics by cohort
| Measure |
Docetaxel
n=612 Participants
Docetaxel 75 milligrams per square meter (mg/m\^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=613 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Total
n=1225 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.9 Years
STANDARD_DEVIATION 9.2 • n=612 Participants
|
62.7 Years
STANDARD_DEVIATION 9.8 • n=613 Participants
|
62.8 Years
STANDARD_DEVIATION 9.5 • n=1225 Participants
|
|
Sex: Female, Male
Female
|
233 Participants
n=612 Participants
|
234 Participants
n=613 Participants
|
467 Participants
n=1225 Participants
|
|
Sex: Female, Male
Male
|
379 Participants
n=612 Participants
|
379 Participants
n=613 Participants
|
758 Participants
n=1225 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
42 Participants
n=612 Participants
|
48 Participants
n=613 Participants
|
90 Participants
n=1225 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
541 Participants
n=612 Participants
|
540 Participants
n=613 Participants
|
1081 Participants
n=1225 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
29 Participants
n=612 Participants
|
25 Participants
n=613 Participants
|
54 Participants
n=1225 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=2 Participants • SP-ITT Population
|
1 Participants
n=1 Participants • SP-ITT Population
|
3 Participants
n=3 Participants • SP-ITT Population
|
|
Race/Ethnicity, Customized
Asian
|
125 Participants
n=125 Participants • SP-ITT Population
|
124 Participants
n=124 Participants • SP-ITT Population
|
249 Participants
n=249 Participants • SP-ITT Population
|
|
Race/Ethnicity, Customized
Black or African American
|
16 Participants
n=16 Participants • SP-ITT Population
|
11 Participants
n=11 Participants • SP-ITT Population
|
27 Participants
n=27 Participants • SP-ITT Population
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
2 Participants
n=2 Participants • SP-ITT Population
|
3 Participants
n=3 Participants • SP-ITT Population
|
5 Participants
n=5 Participants • SP-ITT Population
|
|
Race/Ethnicity, Customized
White
|
432 Participants
n=432 Participants • SP-ITT Population
|
438 Participants
n=438 Participants • SP-ITT Population
|
870 Participants
n=870 Participants • SP-ITT Population
|
|
Race/Ethnicity, Customized
Other
|
12 Participants
n=12 Participants • SP-ITT Population
|
11 Participants
n=11 Participants • SP-ITT Population
|
23 Participants
n=23 Participants • SP-ITT Population
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=1 Participants • SP-ITT Population
|
2 Participants
n=2 Participants • SP-ITT Population
|
3 Participants
n=3 Participants • SP-ITT Population
|
|
Race/Ethnicity, Customized
Unknown
|
22 Participants
n=22 Participants • SP-ITT Population
|
23 Participants
n=23 Participants • SP-ITT Population
|
45 Participants
n=45 Participants • SP-ITT Population
|
PRIMARY outcome
Timeframe: Baseline until death due to any cause (up to approximately 2.25 years)Population: PP-ITT analysis set included the first 850 randomized ITT participants regardless of whether they received any study drug.
Outcome measures
| Measure |
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants Who Died: PP-ITT
|
70.1 Percentage of Participants
|
63.8 Percentage of Participants
|
PRIMARY outcome
Timeframe: Baseline until death due to any cause (up to approximately 2.25 years)Population: TC1/2/3 or IC1/2/3 subgroup within PP included ITT participants with the corresponding programmed death-ligand 1 (PD-L1) expression status.
Percentage of participants who died among TC1/2/3 or IC1/2/3 subgroup of PP-ITT were reported. TC1 = presence of discernible programmed death-ligand 1 (PD-L1) staining of any intensity in \>/=1% and \<5% TCs; TC2: presence of discernible PD-L1 staining of any intensity in \>/=5% and \<50% TCs; TC3 = presence of discernible PD-L1 staining of any intensity in \>/=50% TCs; IC1 = presence of discernible PD-L1 staining of any intensity in ICs covering between \>/=1% and \<5% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC2 = presence of discernible PD-L1 staining of any intensity in ICs covering between \>/=5% and \<10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC3 = presence of discernible PD-L1 staining of any intensity in ICs covering \>/=10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma.
Outcome measures
| Measure |
Atezolizumab
n=222 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=241 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP
|
67.1 Percentage of Participants
|
62.7 Percentage of Participants
|
PRIMARY outcome
Timeframe: Baseline until death due to any cause (up to approximately 2.25 years)Population: The PP-ITT analysis set.
OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
Outcome measures
| Measure |
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
Overall Survival (OS): PP-ITT
|
9.6 Months
Interval 8.6 to 11.2
|
13.8 Months
Interval 11.8 to 15.7
|
PRIMARY outcome
Timeframe: Baseline until death due to any cause (up to approximately 2.25 years)Population: TC1/2/3 or IC1/2/3 subgroup of PP
OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
Outcome measures
| Measure |
Atezolizumab
n=222 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=241 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
OS: TC1/2/3 or IC1/2/3 Subgroup of PP
|
10.3 Months
Interval 8.8 to 12.0
|
15.7 Months
Interval 12.6 to 18.0
|
PRIMARY outcome
Timeframe: Baseline until death due to any cause (up to approximately 2.87 years)Population: Secondary population (SP) ITT analysis set included all 1225 randomized participants regardless of whether they received any study drug.
OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
Outcome measures
| Measure |
Atezolizumab
n=612 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=613 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
OS: SP-ITT
|
9.8 Months
Interval 8.8 to 11.3
|
13.3 Months
Interval 11.3 to 14.9
|
PRIMARY outcome
Timeframe: Baseline until death from any cause (approximately 2.87 years)Population: TC1/2/3 Or IC1/2/3 Subgroup of SP.
OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
Outcome measures
| Measure |
Atezolizumab
n=337 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=347 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
OS: TC1/2/3 Or IC1/2/3 Subgroup of SP
|
10.8 Months
Interval 9.3 to 12.0
|
14.3 Months
Interval 12.4 to 16.7
|
PRIMARY outcome
Timeframe: Baseline until death due to any cause (up to approximately 2.87 years)Population: TC2/3 or IC2/3 Subgroup of SP.
OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
Outcome measures
| Measure |
Atezolizumab
n=182 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=168 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
OS: TC2/3 or IC2/3 Subgroup of SP
|
11.4 Months
Interval 9.3 to 12.9
|
16.6 Months
Interval 13.6 to 20.1
|
PRIMARY outcome
Timeframe: Baseline until death due to any cause (up to approximately 2.87 years)Population: TC3 or IC3 Subgroup of SP.
OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
Outcome measures
| Measure |
Atezolizumab
n=85 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=89 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
OS: TC3 or IC3 Subgroup of SP
|
9.7 Months
Interval 7.9 to 11.6
|
20.5 Months
Interval 16.8 to 30.2
|
SECONDARY outcome
Timeframe: Baseline up to PD or Death (up to approximately 2.25 years)Population: The PP-ITT analysis set
PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 millimeters (mm), or presence of new lesions.
Outcome measures
| Measure |
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants With Disease Progression (PD) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death: PP-ITT
|
88.2 Percentage of Participants
|
89.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline up to PD or Death (up to approximately 2.25 years)Population: TC1/2/3 or IC1/2/3 subgroup of PP
PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.
Outcome measures
| Measure |
Atezolizumab
n=222 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=241 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants With PD as Determined by Investigator Using RECIST v1.1 or Death: TC1/2/3 or IC1/2/3 Subgroup of PP
|
86.9 Percentage of Participants
|
89.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)Population: The PP-ITT analysis set.
PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.
Outcome measures
| Measure |
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
Progression-Free Survival (PFS) as Determined by Investigator Using RECIST v1.1: PP-ITT
|
4.0 Months
Interval 3.3 to 4.2
|
2.8 Months
Interval 2.6 to 3.0
|
SECONDARY outcome
Timeframe: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)Population: The TC1/2/3 or IC1/2/3 subgroup of PP
PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.
Outcome measures
| Measure |
Atezolizumab
n=222 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=241 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
PFS as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
|
4.1 Months
Interval 2.9 to 4.3
|
2.8 Months
Interval 2.6 to 4.0
|
SECONDARY outcome
Timeframe: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)Population: The PP-ITT analysis set.
Objective response is defined as a complete response (CR) or partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than \[\<\] 10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions.
Outcome measures
| Measure |
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants With Objective Response as Determined Using RECIST v1.1: PP-ITT
|
13.4 Percentage of Participants
Interval 10.32 to 17.02
|
13.6 Percentage of Participants
Interval 10.53 to 17.28
|
SECONDARY outcome
Timeframe: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)Population: The TC1/2/3 or IC1/2/3 subgroup of PP
Objective response is defined as a CR or PR as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions.
Outcome measures
| Measure |
Atezolizumab
n=222 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=241 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants With Objective Response as Determined Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
|
16.2 Percentage of Participants
Interval 11.62 to 21.74
|
17.8 Percentage of Participants
Interval 13.22 to 23.27
|
SECONDARY outcome
Timeframe: From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)Population: The PP-ITT analysis set.
DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.
Outcome measures
| Measure |
Atezolizumab
n=57 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=58 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1: PP-ITT
|
6.2 Months
Interval 4.9 to 7.6
|
16.3 Months
Interval 10.0 to
Data not reported because the upper limit of confidence interval (CI) was not estimable due to higher number of censored participants.
|
SECONDARY outcome
Timeframe: From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)Population: The TC1/2/3 or IC1/2/3 subgroup of PP
DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.
Outcome measures
| Measure |
Atezolizumab
n=36 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=43 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
DOR as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
|
6.2 Months
Interval 4.9 to 9.2
|
16.0 Months
Interval 9.7 to
Data not reported because the upper limit of CI was not estimable due to higher number of censored participants.
|
SECONDARY outcome
Timeframe: Baseline up to approximately 2.25 years (assessed at predose [Hour {Hr} 0] on Day 1 of Cycles 1, 2, 3, 4, 8, 16, then every 8 cycles up to end of treatment (EOT) [approximately 2.25 years]; 120 days after EOT [approximately 2.25 years] [1 Cycle=21 days])Population: ATA evaluable population included all participants who received atezolizumab treatment and had at least one post treatment ATA result.
Outcome measures
| Measure |
Atezolizumab
n=565 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab
|
30.4 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Predose (Hr 0), 30 minutes (min) post-infusion (infusion duration: 60 min) on Cycle 1 Day 1 (1 Cycle=21 days)Population: Pharmacokinetic (PK) evaluable population included participants who received atezolizumab treatment and had at least one measurable PK concentration.
Outcome measures
| Measure |
Atezolizumab
n=606 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
Maximum Observed Serum Atezolizumab Concentration (Cmax)
|
400 Microgram per milliliter (mcg/mL)
Standard Deviation 127
|
—
|
SECONDARY outcome
Timeframe: Predose (Hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, 24, 32, EOT (approximately 2.25 years); 120 days after EOT (approximately 2.25 years) (1 Cycle=21 days)Population: PK evaluable participants. Here, 'n' signifies those participants evaluated for this measure at specific time point. All 606 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
Outcome measures
| Measure |
Atezolizumab
n=606 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
Minimum Observed Serum Atezolizumab Concentration (Cmin)
C1D1 (n= 593)
|
2.59 mcg/mL
Standard Deviation 30.9
|
—
|
|
Minimum Observed Serum Atezolizumab Concentration (Cmin)
C2D1 (n= 534)
|
83.2 mcg/mL
Standard Deviation 31.0
|
—
|
|
Minimum Observed Serum Atezolizumab Concentration (Cmin)
C3D1 (n= 445)
|
130 mcg/mL
Standard Deviation 55.8
|
—
|
|
Minimum Observed Serum Atezolizumab Concentration (Cmin)
C4D1 (n= 405)
|
158 mcg/mL
Standard Deviation 66.4
|
—
|
|
Minimum Observed Serum Atezolizumab Concentration (Cmin)
C16D1 (n= 132)
|
226 mcg/mL
Standard Deviation 105
|
—
|
|
Minimum Observed Serum Atezolizumab Concentration (Cmin)
C24D1 (n= 63)
|
250 mcg/mL
Standard Deviation 99.8
|
—
|
|
Minimum Observed Serum Atezolizumab Concentration (Cmin)
C32D1 (n= 11)
|
277 mcg/mL
Standard Deviation 117
|
—
|
|
Minimum Observed Serum Atezolizumab Concentration (Cmin)
EOT (n= 347)
|
144 mcg/mL
Standard Deviation 101
|
—
|
|
Minimum Observed Serum Atezolizumab Concentration (Cmin)
120 days after EOT (n= 124)
|
10.4 mcg/mL
Standard Deviation 20.0
|
—
|
|
Minimum Observed Serum Atezolizumab Concentration (Cmin)
C8D1 (n= 222)
|
205 mcg/mL
Standard Deviation 99.4
|
—
|
SECONDARY outcome
Timeframe: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years) (1 Cycle = 21 days)Population: The PP-ITT analysis set.
TTD in patient-reported lung cancer symptoms (pain in chest or in arm/shoulder, dyspnea, or cough) was a composite endpoint defined as the time from randomization to the earliest time the participant's scale scores showed a 10 point or greater increase after baseline in any of the symptoms. A \>/=10-point change in the score perceived by participants was considered as clinically significant. The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity.
Outcome measures
| Measure |
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms, Using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ) Lung Cancer Supplemental Module 13 (LC13)
Pain in Chest
|
8.3 Months
Interval 4.6 to 12.5
|
18.0 Months
Interval 11.0 to
Data not reported because the upper limit of CI was not estimable due to higher number of censored participants.
|
|
Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms, Using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ) Lung Cancer Supplemental Module 13 (LC13)
Cough
|
5.6 Months
Interval 4.0 to 12.8
|
5.5 Months
Interval 4.2 to 7.9
|
|
Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms, Using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ) Lung Cancer Supplemental Module 13 (LC13)
Dyspnea
|
2.1 Months
Interval 1.6 to 2.3
|
1.8 Months
Interval 1.5 to 2.3
|
|
Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms, Using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ) Lung Cancer Supplemental Module 13 (LC13)
Arm/Shoulder Pain
|
6.2 Months
Interval 4.9 to 14.7
|
8.3 Months
Interval 5.8 to 12.8
|
SECONDARY outcome
Timeframe: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)Population: The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
EORTC QLQ-C30 included global health status (GHS)/quality of life (QOL), functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
Outcome measures
| Measure |
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: Baseline (n= 390, 413)
|
26.58 Units on a scale
Standard Deviation 31.57
|
22.92 Units on a scale
Standard Deviation 29.41
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: Cycle (C) 2 Day (D) 1(n= 342, 368)
|
27.49 Units on a scale
Standard Deviation 30.39
|
26.99 Units on a scale
Standard Deviation 31.16
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C3D1(n= 256, 304)
|
21.35 Units on a scale
Standard Deviation 28.84
|
21.16 Units on a scale
Standard Deviation 28.94
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C4D1(n= 224, 279)
|
18.75 Units on a scale
Standard Deviation 25.36
|
18.40 Units on a scale
Standard Deviation 26.60
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C5D1(n= 166, 238)
|
18.88 Units on a scale
Standard Deviation 23.89
|
16.67 Units on a scale
Standard Deviation 27.52
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C6D1(n= 151, 224)
|
18.98 Units on a scale
Standard Deviation 25.68
|
14.88 Units on a scale
Standard Deviation 25.39
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C7D1(n= 88, 190)
|
15.91 Units on a scale
Standard Deviation 24.75
|
12.46 Units on a scale
Standard Deviation 23.06
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C8D1(n= 72, 170)
|
13.89 Units on a scale
Standard Deviation 22.20
|
12.94 Units on a scale
Standard Deviation 23.27
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C9D1(n= 50, 153)
|
8.00 Units on a scale
Standard Deviation 18.52
|
11.33 Units on a scale
Standard Deviation 22.35
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C10D1(n= 47, 146)
|
7.80 Units on a scale
Standard Deviation 15.87
|
12.33 Units on a scale
Standard Deviation 21.45
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C11D1(n= 37, 134)
|
11.71 Units on a scale
Standard Deviation 23.85
|
11.44 Units on a scale
Standard Deviation 22.43
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C12D1(n= 30, 132)
|
11.11 Units on a scale
Standard Deviation 20.22
|
8.84 Units on a scale
Standard Deviation 18.81
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C13D1(n= 19, 123)
|
10.53 Units on a scale
Standard Deviation 15.92
|
8.40 Units on a scale
Standard Deviation 15.74
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C14D1(n= 18, 120)
|
7.41 Units on a scale
Standard Deviation 14.26
|
10.00 Units on a scale
Standard Deviation 17.61
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C15D1(n= 16, 113)
|
6.25 Units on a scale
Standard Deviation 13.44
|
12.39 Units on a scale
Standard Deviation 22.80
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C16D1(n= 13, 109)
|
7.69 Units on a scale
Standard Deviation 14.62
|
10.09 Units on a scale
Standard Deviation 19.51
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C17D1(n= 11, 98)
|
6.06 Units on a scale
Standard Deviation 13.48
|
7.82 Units on a scale
Standard Deviation 18.41
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C18D1(n= 10, 91)
|
6.67 Units on a scale
Standard Deviation 14.05
|
8.06 Units on a scale
Standard Deviation 18.15
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C19D1(n= 9, 84)
|
7.41 Units on a scale
Standard Deviation 14.70
|
9.13 Units on a scale
Standard Deviation 18.18
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C20D1(n= 9, 80)
|
11.11 Units on a scale
Standard Deviation 23.57
|
9.58 Units on a scale
Standard Deviation 21.34
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C21D1(n= 9, 75)
|
3.70 Units on a scale
Standard Deviation 11.11
|
12.44 Units on a scale
Standard Deviation 26.15
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C22D1(n= 8, 69)
|
8.33 Units on a scale
Standard Deviation 15.43
|
6.76 Units on a scale
Standard Deviation 16.74
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C23D1(n= 8, 66)
|
8.33 Units on a scale
Standard Deviation 15.43
|
7.58 Units on a scale
Standard Deviation 17.34
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C24D1(n= 5, 64)
|
13.33 Units on a scale
Standard Deviation 18.26
|
8.33 Units on a scale
Standard Deviation 15.71
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C25D1(n= 3, 60)
|
0.00 Units on a scale
Standard Deviation 0.00
|
6.11 Units on a scale
Standard Deviation 13.01
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C26D1(n= 3, 55)
|
22.22 Units on a scale
Standard Deviation 19.24
|
5.45 Units on a scale
Standard Deviation 12.45
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C27D1(n= 3, 52)
|
0.00 Units on a scale
Standard Deviation 0.00
|
9.62 Units on a scale
Standard Deviation 19.06
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C28D1(n= 1, 49)
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because standard deviation (SD) was non-estimable since only 1 participant was evaluated for this category.
|
7.48 Units on a scale
Standard Deviation 15.61
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C29D1(n= 2, 40)
|
33.33 Units on a scale
Standard Deviation 47.14
|
9.17 Units on a scale
Standard Deviation 16.86
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C30D1(n= 1, 31)
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
1.08 Units on a scale
Standard Deviation 5.99
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C31D1(n= 0, 24)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
6.94 Units on a scale
Standard Deviation 13.83
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C32D1(n= 0, 22)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
7.58 Units on a scale
Standard Deviation 22.84
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C33D1(n= 0,16)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
8.33 Units on a scale
Standard Deviation 25.82
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C34D1(n= 0, 14)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
4.76 Units on a scale
Standard Deviation 17.82
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C35D1(n= 0, 12)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
8.33 Units on a scale
Standard Deviation 20.72
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C36D1(n= 0, 8)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
4.17 Units on a scale
Standard Deviation 11.78
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C37D1(n= 0, 5)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
6.67 Units on a scale
Standard Deviation 14.91
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: C38D1(n= 0, 2)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
0.00 Units on a scale
Standard Deviation 0.00
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: End of treatment (EOT)(n= 265, 246)
|
29.81 Units on a scale
Standard Deviation 31.85
|
31.98 Units on a scale
Standard Deviation 33.51
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: Pro Week 6 Pd(n= 0,1)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
33.33 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Appetite Loss: Survival Follow-up (FU) 1 (n= 2, 1)
|
50.00 Units on a scale
Standard Deviation 70.71
|
66.67 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: Baseline (n= 388, 410)
|
19.93 Units on a scale
Standard Deviation 27.39
|
16.50 Units on a scale
Standard Deviation 26.81
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C2D1(n= 339, 363)
|
19.47 Units on a scale
Standard Deviation 26.42
|
18.09 Units on a scale
Standard Deviation 26.92
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C3D1(n= 255, 304)
|
19.74 Units on a scale
Standard Deviation 26.91
|
15.13 Units on a scale
Standard Deviation 23.71
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C4D1(n= 224, 277)
|
17.86 Units on a scale
Standard Deviation 23.38
|
14.56 Units on a scale
Standard Deviation 23.58
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C5D1(n= 166, 236)
|
13.05 Units on a scale
Standard Deviation 21.33
|
12.15 Units on a scale
Standard Deviation 21.16
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C6D1(n= 151, 225)
|
14.35 Units on a scale
Standard Deviation 23.89
|
12.89 Units on a scale
Standard Deviation 22.42
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C7D1(n= 87, 188)
|
13.41 Units on a scale
Standard Deviation 20.62
|
11.52 Units on a scale
Standard Deviation 21.04
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C8D1(n= 72, 171)
|
8.33 Units on a scale
Standard Deviation 15.57
|
12.28 Units on a scale
Standard Deviation 21.36
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C9D1(n= 50, 153)
|
9.33 Units on a scale
Standard Deviation 19.10
|
10.68 Units on a scale
Standard Deviation 17.79
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C10D1(n= 47, 146)
|
9.22 Units on a scale
Standard Deviation 17.99
|
9.82 Units on a scale
Standard Deviation 17.58
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C11D1(n= 37, 134)
|
5.41 Units on a scale
Standard Deviation 12.46
|
9.95 Units on a scale
Standard Deviation 17.83
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C12D1(n= 30, 132)
|
11.11 Units on a scale
Standard Deviation 20.22
|
10.86 Units on a scale
Standard Deviation 18.65
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C13D1(n= 19, 124)
|
5.26 Units on a scale
Standard Deviation 12.49
|
8.60 Units on a scale
Standard Deviation 15.83
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C14D1(n= 17, 121)
|
15.69 Units on a scale
Standard Deviation 23.91
|
9.09 Units on a scale
Standard Deviation 16.67
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C15D1(n= 15, 113)
|
2.22 Units on a scale
Standard Deviation 8.61
|
10.03 Units on a scale
Standard Deviation 17.75
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C16D1(n= 13, 109)
|
20.51 Units on a scale
Standard Deviation 32.03
|
9.79 Units on a scale
Standard Deviation 18.87
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C17D1(n= 11, 98)
|
12.12 Units on a scale
Standard Deviation 22.47
|
9.86 Units on a scale
Standard Deviation 19.27
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C18D1(n= 10, 92)
|
6.67 Units on a scale
Standard Deviation 14.05
|
9.06 Units on a scale
Standard Deviation 17.89
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C19D1(n= 9, 83)
|
7.41 Units on a scale
Standard Deviation 14.70
|
9.64 Units on a scale
Standard Deviation 18.43
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C20D1(n=9, 80)
|
14.81 Units on a scale
Standard Deviation 33.79
|
12.50 Units on a scale
Standard Deviation 23.35
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C21D1(n= 9, 75)
|
7.41 Units on a scale
Standard Deviation 14.70
|
14.22 Units on a scale
Standard Deviation 25.22
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C22D1(n= 8, 69)
|
12.50 Units on a scale
Standard Deviation 24.80
|
11.59 Units on a scale
Standard Deviation 21.26
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C23D1(n= 8, 66)
|
4.17 Units on a scale
Standard Deviation 11.78
|
10.10 Units on a scale
Standard Deviation 20.23
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C24D1(n=5, 65)
|
20.00 Units on a scale
Standard Deviation 29.81
|
9.74 Units on a scale
Standard Deviation 17.40
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C25D1(n= 3, 60)
|
0.00 Units on a scale
Standard Deviation 0.00
|
11.11 Units on a scale
Standard Deviation 19.08
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C26D1(n= 2, 55)
|
0.00 Units on a scale
Standard Deviation 0.00
|
12.12 Units on a scale
Standard Deviation 20.65
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C27D1(n= 3, 52)
|
0.00 Units on a scale
Standard Deviation 0.00
|
13.46 Units on a scale
Standard Deviation 20.09
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C28D1(n= 1, 48)
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
11.81 Units on a scale
Standard Deviation 22.27
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C29D1(n= 2, 40)
|
50.00 Units on a scale
Standard Deviation 70.71
|
15.83 Units on a scale
Standard Deviation 23.86
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C30D1(n= 1, 31)
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
8.60 Units on a scale
Standard Deviation 19.18
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C31D1(n= 0, 24)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
9.72 Units on a scale
Standard Deviation 20.80
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C32D1(n= 0, 22)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
6.06 Units on a scale
Standard Deviation 13.16
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C33D1(n= 0, 16)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
4.17 Units on a scale
Standard Deviation 11.39
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C34D1(n= 0, 14)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
7.14 Units on a scale
Standard Deviation 14.19
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C35D1(n= 0, 12)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
5.56 Units on a scale
Standard Deviation 12.97
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C36D1(n= 0, 8)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
4.17 Units on a scale
Standard Deviation 11.78
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C37D1(n= 0, 5)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
0.00 Units on a scale
Standard Deviation 0.00
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: C38D1(n= 0, 2)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
0.00 Units on a scale
Standard Deviation 0.00
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: EOT (n= 265, 246)
|
19.12 Units on a scale
Standard Deviation 27.28
|
19.78 Units on a scale
Standard Deviation 28.36
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: Pro Week 6 Pd(n= 0,1)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
66.67 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Constipation: Survival FU-1 (n= 2,1)
|
33.33 Units on a scale
Standard Deviation 47.14
|
66.67 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: Baseline (n= 388, 411)
|
5.84 Units on a scale
Standard Deviation 13.77
|
7.22 Units on a scale
Standard Deviation 17.86
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C2D1(n= 339, 361)
|
11.21 Units on a scale
Standard Deviation 20.65
|
7.29 Units on a scale
Standard Deviation 17.72
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C3D1(n= 255, 304)
|
10.07 Units on a scale
Standard Deviation 18.68
|
6.14 Units on a scale
Standard Deviation 15.75
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C4D1(n= 223, 280)
|
8.22 Units on a scale
Standard Deviation 16.35
|
6.67 Units on a scale
Standard Deviation 17.71
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C5D1(n= 166, 238)
|
8.43 Units on a scale
Standard Deviation 17.48
|
6.58 Units on a scale
Standard Deviation 16.16
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C6D1(n= 151, 222)
|
7.51 Units on a scale
Standard Deviation 14.99
|
6.31 Units on a scale
Standard Deviation 14.88
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C7D1(n= 87, 189)
|
10.34 Units on a scale
Standard Deviation 17.10
|
7.94 Units on a scale
Standard Deviation 17.24
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C8D1(n= 72, 171)
|
7.41 Units on a scale
Standard Deviation 15.03
|
8.77 Units on a scale
Standard Deviation 17.56
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C9D1(n= 50, 153)
|
11.33 Units on a scale
Standard Deviation 17.31
|
7.63 Units on a scale
Standard Deviation 16.44
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C10D1(n= 47, 146)
|
7.80 Units on a scale
Standard Deviation 14.27
|
5.48 Units on a scale
Standard Deviation 15.67
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C11D1(n= 36, 134)
|
8.33 Units on a scale
Standard Deviation 14.64
|
4.98 Units on a scale
Standard Deviation 14.46
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C12D1(n= 30, 132)
|
10.00 Units on a scale
Standard Deviation 17.83
|
6.31 Units on a scale
Standard Deviation 16.54
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C13D1(n= 18, 124)
|
11.11 Units on a scale
Standard Deviation 16.17
|
5.65 Units on a scale
Standard Deviation 14.55
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C14D1(n= 17, 121)
|
3.92 Units on a scale
Standard Deviation 11.07
|
9.92 Units on a scale
Standard Deviation 19.07
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C15D1(n= 15, 113)
|
8.89 Units on a scale
Standard Deviation 15.26
|
7.96 Units on a scale
Standard Deviation 17.97
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C16D1(n= 12, 108)
|
13.89 Units on a scale
Standard Deviation 17.16
|
6.48 Units on a scale
Standard Deviation 14.02
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C17D1(n= 11, 98)
|
9.09 Units on a scale
Standard Deviation 15.57
|
7.82 Units on a scale
Standard Deviation 16.44
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C18D1(n= 10, 92)
|
13.33 Units on a scale
Standard Deviation 17.21
|
8.70 Units on a scale
Standard Deviation 17.73
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C19D1(n= 9, 84)
|
14.81 Units on a scale
Standard Deviation 17.57
|
7.94 Units on a scale
Standard Deviation 18.38
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C20D1(n= 9, 80)
|
7.41 Units on a scale
Standard Deviation 14.70
|
6.67 Units on a scale
Standard Deviation 14.43
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C21D1(n= 9, 75)
|
18.52 Units on a scale
Standard Deviation 17.57
|
11.11 Units on a scale
Standard Deviation 18.45
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C22D1(n= 8, 68)
|
16.67 Units on a scale
Standard Deviation 25.20
|
7.84 Units on a scale
Standard Deviation 16.41
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C23D1(n= 8, 66)
|
8.33 Units on a scale
Standard Deviation 15.43
|
6.06 Units on a scale
Standard Deviation 16.44
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C24D1(n= 5, 64)
|
6.67 Units on a scale
Standard Deviation 14.91
|
6.25 Units on a scale
Standard Deviation 16.67
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C25D1(n= 3, 60)
|
0.00 Units on a scale
Standard Deviation 0.00
|
6.11 Units on a scale
Standard Deviation 14.38
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C26D1(n= 3, 55)
|
11.11 Units on a scale
Standard Deviation 19.24
|
10.30 Units on a scale
Standard Deviation 21.15
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C27D1(n= 3, 52)
|
11.11 Units on a scale
Standard Deviation 19.24
|
5.77 Units on a scale
Standard Deviation 15.79
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C28D1(n= 1, 48)
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
4.86 Units on a scale
Standard Deviation 13.73
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C29D1(n= 2, 40)
|
50.00 Units on a scale
Standard Deviation 70.71
|
9.17 Units on a scale
Standard Deviation 18.47
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C30D1(n= 1, 31)
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
7.53 Units on a scale
Standard Deviation 16.58
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C31D1(n= 0, 24)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
6.94 Units on a scale
Standard Deviation 16.97
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C32D1(n= 0, 22)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
12.12 Units on a scale
Standard Deviation 16.41
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C33D1(n= 0, 16)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
8.33 Units on a scale
Standard Deviation 14.91
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C34D1(n= 0, 14)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
4.76 Units on a scale
Standard Deviation 12.10
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C35D1(n= 0, 12)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
5.56 Units on a scale
Standard Deviation 12.97
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C36D1(n= 0, 8)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
4.17 Units on a scale
Standard Deviation 11.78
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C37D1(n= 0, 5)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
6.67 Units on a scale
Standard Deviation 14.91
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: C38D1(n= 0, 2)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
0.00 Units on a scale
Standard Deviation 0.00
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: EOT(n= 265, 246)
|
10.57 Units on a scale
Standard Deviation 19.18
|
9.35 Units on a scale
Standard Deviation 20.39
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: Pro Week 6 Pd(n= 0, 1)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Diarrhea: Survival FU-1 (n= 2, 1)
|
33.33 Units on a scale
Standard Deviation 47.14
|
33.33 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: Baseline (n=387, 411)
|
20.76 Units on a scale
Standard Deviation 27.61
|
18.09 Units on a scale
Standard Deviation 28.32
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C2D1 (n=336, 362)
|
18.45 Units on a scale
Standard Deviation 26.20
|
15.93 Units on a scale
Standard Deviation 26.28
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C3D1 (n=253, 305)
|
16.86 Units on a scale
Standard Deviation 24.24
|
15.63 Units on a scale
Standard Deviation 25.79
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C4D1 (n=219, 280)
|
16.74 Units on a scale
Standard Deviation 23.97
|
15.12 Units on a scale
Standard Deviation 24.72
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C5D1 (n=165, 238)
|
16.57 Units on a scale
Standard Deviation 24.03
|
15.13 Units on a scale
Standard Deviation 25.71
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C6D1 (n=149, 224)
|
15.66 Units on a scale
Standard Deviation 24.06
|
16.67 Units on a scale
Standard Deviation 26.41
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C7D1 (n=86, 189)
|
16.28 Units on a scale
Standard Deviation 24.92
|
17.46 Units on a scale
Standard Deviation 27.41
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C8D1 (n=71, 170)
|
13.15 Units on a scale
Standard Deviation 21.44
|
18.82 Units on a scale
Standard Deviation 27.59
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C9D1 (n=49, 152)
|
16.33 Units on a scale
Standard Deviation 28.16
|
17.54 Units on a scale
Standard Deviation 27.38
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C10D1 (n=46, 146)
|
14.49 Units on a scale
Standard Deviation 23.99
|
17.81 Units on a scale
Standard Deviation 29.08
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C11D1 (n=36, 134)
|
9.26 Units on a scale
Standard Deviation 21.98
|
19.65 Units on a scale
Standard Deviation 30.10
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C12D1 (n=30, 132)
|
12.22 Units on a scale
Standard Deviation 23.95
|
18.43 Units on a scale
Standard Deviation 28.92
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C28D1 (n=1, 48)
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
18.06 Units on a scale
Standard Deviation 26.59
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C29D1 (n=2, 40)
|
50.00 Units on a scale
Standard Deviation 70.71
|
19.17 Units on a scale
Standard Deviation 28.13
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C30D1 (n=1, 31)
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
17.20 Units on a scale
Standard Deviation 25.63
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C31D1(n=0, 24)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
20.83 Units on a scale
Standard Deviation 25.66
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C32D1(n=0, 22)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
21.21 Units on a scale
Standard Deviation 26.32
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C33D1(n=0, 16)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
22.92 Units on a scale
Standard Deviation 29.11
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C34D1(n=0, 14)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
26.19 Units on a scale
Standard Deviation 35.03
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C35D1(n=0, 12)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
27.78 Units on a scale
Standard Deviation 37.15
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C36D1(n=0, 8)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
8.33 Units on a scale
Standard Deviation 15.43
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C37D1(n=0, 5)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
26.67 Units on a scale
Standard Deviation 43.46
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C38D1(n=0, 2)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
16.67 Units on a scale
Standard Deviation 23.57
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: EOT(n=263, 245)
|
21.80 Units on a scale
Standard Deviation 29.23
|
19.46 Units on a scale
Standard Deviation 28.75
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: Pro Week 6 Pd (n=0, 1)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
33.33 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties:Survival FU-1 (n=2,24)
|
83.33 Units on a scale
Standard Deviation 23.57
|
66.67 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: Baseline (n= 388, 413)
|
28.87 Units on a scale
Standard Deviation 30.55
|
26.15 Units on a scale
Standard Deviation 28.72
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C2D1(n= 340, 367)
|
27.55 Units on a scale
Standard Deviation 30.87
|
26.52 Units on a scale
Standard Deviation 28.61
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C3D1(n= 253, 304)
|
25.69 Units on a scale
Standard Deviation 29.15
|
24.89 Units on a scale
Standard Deviation 27.32
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C4D1(n= 222, 279)
|
21.32 Units on a scale
Standard Deviation 26.07
|
23.66 Units on a scale
Standard Deviation 26.48
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C5D1(n= 166, 237)
|
21.49 Units on a scale
Standard Deviation 25.43
|
25.88 Units on a scale
Standard Deviation 29.84
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C6D1(n= 150, 225)
|
22.00 Units on a scale
Standard Deviation 26.71
|
23.41 Units on a scale
Standard Deviation 27.73
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C7D1(n= 87, 189)
|
21.07 Units on a scale
Standard Deviation 25.47
|
23.99 Units on a scale
Standard Deviation 26.65
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C8D1(n= 70, 169)
|
15.24 Units on a scale
Standard Deviation 23.87
|
23.87 Units on a scale
Standard Deviation 26.27
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C9D1(n= 49, 153)
|
16.33 Units on a scale
Standard Deviation 26.46
|
22.88 Units on a scale
Standard Deviation 27.16
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C10D1(n= 46, 144)
|
13.77 Units on a scale
Standard Deviation 19.34
|
21.53 Units on a scale
Standard Deviation 26.87
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C11D1(n= 36, 133)
|
9.26 Units on a scale
Standard Deviation 18.87
|
20.55 Units on a scale
Standard Deviation 27.44
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C12D1(n= 29, 132)
|
16.09 Units on a scale
Standard Deviation 30.37
|
21.46 Units on a scale
Standard Deviation 24.41
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C13D1(n= 17, 124)
|
17.65 Units on a scale
Standard Deviation 29.15
|
23.39 Units on a scale
Standard Deviation 28.51
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C14D1(n= 17, 121)
|
25.49 Units on a scale
Standard Deviation 27.71
|
23.69 Units on a scale
Standard Deviation 26.33
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C15D1(n= 15, 113)
|
22.22 Units on a scale
Standard Deviation 29.99
|
21.53 Units on a scale
Standard Deviation 28.84
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C16D1(n= 13, 108)
|
20.51 Units on a scale
Standard Deviation 25.60
|
21.60 Units on a scale
Standard Deviation 31.01
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C17D1(n= 11, 98)
|
21.21 Units on a scale
Standard Deviation 26.97
|
20.07 Units on a scale
Standard Deviation 28.21
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C18D1(n= 10, 92)
|
20.00 Units on a scale
Standard Deviation 32.20
|
21.38 Units on a scale
Standard Deviation 27.77
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C19D1(n= 9, 83)
|
18.52 Units on a scale
Standard Deviation 24.22
|
22.49 Units on a scale
Standard Deviation 28.09
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C20D1(n= 9, 80)
|
18.52 Units on a scale
Standard Deviation 33.79
|
20.83 Units on a scale
Standard Deviation 29.71
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C21D1(n= 9, 75)
|
22.22 Units on a scale
Standard Deviation 33.33
|
20.89 Units on a scale
Standard Deviation 29.90
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C22D1(n= 8, 69)
|
16.67 Units on a scale
Standard Deviation 35.63
|
18.84 Units on a scale
Standard Deviation 26.49
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C23D1(n= 8, 66)
|
20.83 Units on a scale
Standard Deviation 35.36
|
19.70 Units on a scale
Standard Deviation 28.03
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C24D1(n= 5, 64)
|
26.67 Units on a scale
Standard Deviation 27.89
|
19.79 Units on a scale
Standard Deviation 25.00
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C25D1(n= 3, 60)
|
11.11 Units on a scale
Standard Deviation 19.24
|
18.89 Units on a scale
Standard Deviation 23.26
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C26D1(n= 3, 55)
|
11.11 Units on a scale
Standard Deviation 19.24
|
21.21 Units on a scale
Standard Deviation 27.49
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C27D1(n= 3, 52)
|
11.11 Units on a scale
Standard Deviation 19.24
|
19.23 Units on a scale
Standard Deviation 28.27
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C28D1(n= 1, 49)
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
21.09 Units on a scale
Standard Deviation 27.80
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C29D1(n= 2, 40)
|
33.33 Units on a scale
Standard Deviation 47.14
|
21.67 Units on a scale
Standard Deviation 26.74
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C30D1(n= 1, 31)
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
20.43 Units on a scale
Standard Deviation 28.12
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C31D1(n= 0, 24)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
20.83 Units on a scale
Standard Deviation 27.47
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C32D1(n= 0, 22)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
19.70 Units on a scale
Standard Deviation 26.55
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C33D1(n= 0, 16)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
20.83 Units on a scale
Standard Deviation 34.16
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C34D1(n= 0, 14)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
23.81 Units on a scale
Standard Deviation 24.21
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C35D1(n= 0, 12)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
25.00 Units on a scale
Standard Deviation 28.87
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C36D1(n= 0, 8)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
25.00 Units on a scale
Standard Deviation 23.57
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C37D1(n= 0, 5)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
33.33 Units on a scale
Standard Deviation 23.57
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: C38D1(n= 0, 2)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
16.67 Units on a scale
Standard Deviation 23.57
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: EOT(n= 264, 246)
|
28.91 Units on a scale
Standard Deviation 30.65
|
29.95 Units on a scale
Standard Deviation 30.30
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: Pro Week Pd(n= 0, 1)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
66.67 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Insomnia: Survival FU-1 (n= 2, 1)
|
50.00 Units on a scale
Standard Deviation 70.71
|
100.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C1D1 (n= 389, 412)
|
33.50 Units on a scale
Standard Deviation 31.11
|
32.04 Units on a scale
Standard Deviation 28.73
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C2D1 (n= 341, 368)
|
32.55 Units on a scale
Standard Deviation 29.03
|
31.88 Units on a scale
Standard Deviation 29.70
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C3D1 (n= 255, 302)
|
29.93 Units on a scale
Standard Deviation 27.54
|
27.15 Units on a scale
Standard Deviation 26.73
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C4D1 (n= 389, 277)
|
28.38 Units on a scale
Standard Deviation 24.37
|
28.28 Units on a scale
Standard Deviation 27.48
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C5D1 (n= 222, 236)
|
29.52 Units on a scale
Standard Deviation 24.46
|
27.82 Units on a scale
Standard Deviation 27.03
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C6D1 (n= 166, 222)
|
30.02 Units on a scale
Standard Deviation 26.32
|
26.88 Units on a scale
Standard Deviation 25.63
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C7D1 (n= 151, 188)
|
27.13 Units on a scale
Standard Deviation 25.31
|
25.53 Units on a scale
Standard Deviation 25.99
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C8D1 (n= 86, 169)
|
28.70 Units on a scale
Standard Deviation 29.76
|
26.43 Units on a scale
Standard Deviation 26.70
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C9D1 (n= 72, 152)
|
26.67 Units on a scale
Standard Deviation 28.57
|
24.12 Units on a scale
Standard Deviation 24.92
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C10D1 (n= 50, 146)
|
27.66 Units on a scale
Standard Deviation 28.93
|
23.52 Units on a scale
Standard Deviation 23.54
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C11D1 (n= 47, 134)
|
25.23 Units on a scale
Standard Deviation 30.84
|
22.89 Units on a scale
Standard Deviation 25.00
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C12D1 (n= 37, 132)
|
26.67 Units on a scale
Standard Deviation 26.84
|
22.73 Units on a scale
Standard Deviation 25.83
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C13D1 (n= 30, 123)
|
19.30 Units on a scale
Standard Deviation 23.08
|
25.47 Units on a scale
Standard Deviation 26.68
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C14D1 (n= 19, 119)
|
20.37 Units on a scale
Standard Deviation 25.92
|
21.85 Units on a scale
Standard Deviation 25.47
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C15D1 (n= 16, 113)
|
16.67 Units on a scale
Standard Deviation 17.21
|
22.71 Units on a scale
Standard Deviation 24.51
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C16D1 (n= 13, 109)
|
20.51 Units on a scale
Standard Deviation 16.88
|
21.71 Units on a scale
Standard Deviation 25.00
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C17D1 (n= 11, 98)
|
15.15 Units on a scale
Standard Deviation 17.41
|
21.43 Units on a scale
Standard Deviation 23.57
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C18D1 (n= 10, 92)
|
20.00 Units on a scale
Standard Deviation 17.21
|
22.83 Units on a scale
Standard Deviation 25.64
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C19D1 (n= 9, 84)
|
11.11 Units on a scale
Standard Deviation 16.67
|
23.41 Units on a scale
Standard Deviation 23.59
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C20D1 (n= 9, 80)
|
18.52 Units on a scale
Standard Deviation 17.57
|
21.67 Units on a scale
Standard Deviation 24.36
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C21D1 (n= 9, 75)
|
18.52 Units on a scale
Standard Deviation 17.57
|
19.11 Units on a scale
Standard Deviation 20.63
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C22D1 (n= 8, 68)
|
20.83 Units on a scale
Standard Deviation 35.36
|
20.59 Units on a scale
Standard Deviation 23.06
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C23D1 (n= 8, 65)
|
12.50 Units on a scale
Standard Deviation 17.25
|
18.46 Units on a scale
Standard Deviation 21.27
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C24D1 (n= 5, 64)
|
6.67 Units on a scale
Standard Deviation 14.91
|
19.79 Units on a scale
Standard Deviation 24.28
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C25D1 (n= 3, 60)
|
11.11 Units on a scale
Standard Deviation 19.24
|
20.00 Units on a scale
Standard Deviation 22.30
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C26D1 (n= 3, 55)
|
0.00 Units on a scale
Standard Deviation 0.00
|
20.00 Units on a scale
Standard Deviation 24.51
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C27D1 (n= 3, 52)
|
0.00 Units on a scale
Standard Deviation 0.00
|
16.03 Units on a scale
Standard Deviation 19.23
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C28D1 (n= 1, 49)
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
17.01 Units on a scale
Standard Deviation 20.55
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C29D1 (n= 2, 40)
|
33.33 Units on a scale
Standard Deviation 47.14
|
15.00 Units on a scale
Standard Deviation 21.28
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C30D1 (n= 1, 31)
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
16.13 Units on a scale
Standard Deviation 18.99
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C31D1 (n= 0, 24)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
22.22 Units on a scale
Standard Deviation 23.40
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C32D1 (n= 0, 22)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
22.73 Units on a scale
Standard Deviation 21.54
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C33D1 (n= 0, 16)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
25.00 Units on a scale
Standard Deviation 31.03
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C34D1 (n= 0, 14)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
26.19 Units on a scale
Standard Deviation 26.73
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C35D1 (n= 0, 12)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
25.00 Units on a scale
Standard Deviation 25.13
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C36D1 (n= 0, 8)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
20.83 Units on a scale
Standard Deviation 17.25
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C37D1 (n= 0, 5)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
26.67 Units on a scale
Standard Deviation 14.91
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: C38D1 (n= 0, 2)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
33.33 Units on a scale
Standard Deviation 0.00
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: EOT(n= 266, 247)
|
38.72 Units on a scale
Standard Deviation 30.51
|
39.41 Units on a scale
Standard Deviation 32.57
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: Pro Week 6 Pd (n= 0, 1)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
33.33 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Dyspnea: Survival Follow-Up 1 (n= 2, 1)
|
33.33 Units on a scale
Standard Deviation 47.14
|
33.33 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C13D1 (n=18, 122)
|
12.96 Units on a scale
Standard Deviation 25.92
|
18.31 Units on a scale
Standard Deviation 29.10
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C14D1 (n=17, 121)
|
15.69 Units on a scale
Standard Deviation 26.66
|
18.46 Units on a scale
Standard Deviation 29.17
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C15D1 (n=15, 113)
|
6.67 Units on a scale
Standard Deviation 18.69
|
18.29 Units on a scale
Standard Deviation 28.86
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C16D1 (n=12, 109)
|
13.89 Units on a scale
Standard Deviation 30.01
|
18.65 Units on a scale
Standard Deviation 29.20
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C17D1 (n=11, 98)
|
15.15 Units on a scale
Standard Deviation 22.92
|
18.37 Units on a scale
Standard Deviation 27.55
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C18D1 (n=10, 92)
|
10.00 Units on a scale
Standard Deviation 22.50
|
19.57 Units on a scale
Standard Deviation 28.45
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C19D1 (n=9, 84)
|
3.70 Units on a scale
Standard Deviation 11.11
|
19.05 Units on a scale
Standard Deviation 28.94
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C20D1 (n=9, 80)
|
11.11 Units on a scale
Standard Deviation 33.33
|
18.75 Units on a scale
Standard Deviation 27.99
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C21D1 (n=9, 75)
|
11.11 Units on a scale
Standard Deviation 33.33
|
23.11 Units on a scale
Standard Deviation 30.99
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C22D1 (n=8, 68)
|
12.50 Units on a scale
Standard Deviation 35.36
|
18.63 Units on a scale
Standard Deviation 28.44
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C23D1 (n=7, 66)
|
9.52 Units on a scale
Standard Deviation 25.20
|
21.72 Units on a scale
Standard Deviation 30.66
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C24D1 (n=5, 64)
|
13.33 Units on a scale
Standard Deviation 29.81
|
20.83 Units on a scale
Standard Deviation 29.99
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C25D1 (n=3, 60)
|
0.00 Units on a scale
Standard Deviation 0.00
|
21.67 Units on a scale
Standard Deviation 31.19
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C26D1 (n=3, 55)
|
0.00 Units on a scale
Standard Deviation 0.00
|
20.00 Units on a scale
Standard Deviation 30.50
|
|
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Financial Difficulties: C27D1 (n=3, 52)
|
0.00 Units on a scale
Standard Deviation 0.00
|
17.31 Units on a scale
Standard Deviation 28.38
|
SECONDARY outcome
Timeframe: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)Population: The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
Outcome measures
| Measure |
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: Baseline (n= 390, 411)
|
83.38 Units on a scale
Standard Deviation 20.68
|
85.16 Units on a scale
Standard Deviation 19.16
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C2D1 (n= 341, 363)
|
83.38 Units on a scale
Standard Deviation 21.64
|
84.94 Units on a scale
Standard Deviation 19.30
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C3D1(n= 256, 305)
|
84.05 Units on a scale
Standard Deviation 19.82
|
86.28 Units on a scale
Standard Deviation 17.32
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C4D1(n= 224, 281)
|
84.82 Units on a scale
Standard Deviation 19.27
|
85.35 Units on a scale
Standard Deviation 19.87
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C5D1(n= 166, 238)
|
86.04 Units on a scale
Standard Deviation 17.24
|
84.38 Units on a scale
Standard Deviation 19.73
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C6D1(n= 151, 224)
|
86.09 Units on a scale
Standard Deviation 18.20
|
84.45 Units on a scale
Standard Deviation 20.27
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C7D1(n= 87, 189)
|
87.55 Units on a scale
Standard Deviation 16.32
|
84.74 Units on a scale
Standard Deviation 18.93
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C8D1(n= 72, 171)
|
89.58 Units on a scale
Standard Deviation 13.83
|
85.58 Units on a scale
Standard Deviation 18.87
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C9D1(n= 50, 153)
|
90.00 Units on a scale
Standard Deviation 14.29
|
85.95 Units on a scale
Standard Deviation 18.65
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C10D1(n= 47, 146)
|
91.13 Units on a scale
Standard Deviation 11.96
|
86.53 Units on a scale
Standard Deviation 19.31
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C11D1(n= 36, 134)
|
92.59 Units on a scale
Standard Deviation 10.87
|
85.95 Units on a scale
Standard Deviation 19.91
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C12D1(n= 30, 132)
|
91.11 Units on a scale
Standard Deviation 12.17
|
84.22 Units on a scale
Standard Deviation 20.52
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C13D1(n= 18, 124)
|
90.74 Units on a scale
Standard Deviation 11.75
|
84.27 Units on a scale
Standard Deviation 21.50
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C14D1(n= 17, 121)
|
92.16 Units on a scale
Standard Deviation 11.96
|
85.67 Units on a scale
Standard Deviation 18.30
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C15D1(n= 15, 113)
|
93.33 Units on a scale
Standard Deviation 10.54
|
85.10 Units on a scale
Standard Deviation 19.08
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C16D1(n= 12, 109)
|
97.22 Units on a scale
Standard Deviation 6.49
|
85.32 Units on a scale
Standard Deviation 21.12
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C17D1(n= 11, 98)
|
96.97 Units on a scale
Standard Deviation 6.74
|
85.37 Units on a scale
Standard Deviation 20.48
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C18D1(n= 10, 92)
|
91.67 Units on a scale
Standard Deviation 11.79
|
82.97 Units on a scale
Standard Deviation 20.52
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C19D1(n= 9, 84)
|
92.59 Units on a scale
Standard Deviation 12.11
|
83.53 Units on a scale
Standard Deviation 20.12
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C20D1(n= 9, 80)
|
90.74 Units on a scale
Standard Deviation 14.70
|
82.29 Units on a scale
Standard Deviation 22.87
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C21D1(n= 9, 75)
|
87.04 Units on a scale
Standard Deviation 23.24
|
83.78 Units on a scale
Standard Deviation 20.32
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C22D1(n= 8, 68)
|
89.58 Units on a scale
Standard Deviation 12.40
|
84.56 Units on a scale
Standard Deviation 21.03
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C23D1(n= 8, 66)
|
95.83 Units on a scale
Standard Deviation 7.72
|
84.09 Units on a scale
Standard Deviation 20.55
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C24D1(n= 5, 64)
|
83.33 Units on a scale
Standard Deviation 23.57
|
83.85 Units on a scale
Standard Deviation 23.56
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C25D1(n= 3, 60)
|
72.22 Units on a scale
Standard Deviation 25.46
|
83.61 Units on a scale
Standard Deviation 21.59
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C26D1(n= 3, 55)
|
77.78 Units on a scale
Standard Deviation 19.24
|
82.73 Units on a scale
Standard Deviation 21.51
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C27D1(n= 3, 52)
|
88.89 Units on a scale
Standard Deviation 19.24
|
85.26 Units on a scale
Standard Deviation 20.25
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C28D1(n= 1, 48)
|
100.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
85.07 Units on a scale
Standard Deviation 20.98
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C29D1(n= 2, 40)
|
50.00 Units on a scale
Standard Deviation 70.71
|
83.75 Units on a scale
Standard Deviation 20.84
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C30D1(n= 1, 31)
|
100.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
86.02 Units on a scale
Standard Deviation 20.68
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C31D1(n= 0, 24)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
80.56 Units on a scale
Standard Deviation 21.23
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C32D1(n= 0, 22)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
82.58 Units on a scale
Standard Deviation 22.11
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C33D1(n= 0,16)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
77.08 Units on a scale
Standard Deviation 25.73
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C34D1(n= 0, 14)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
80.95 Units on a scale
Standard Deviation 24.33
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C35D1(n= 0, 12)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
76.39 Units on a scale
Standard Deviation 21.86
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C36D1(n= 0, 8)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
83.33 Units on a scale
Standard Deviation 15.43
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C37D1(n= 0, 5)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
83.33 Units on a scale
Standard Deviation 16.67
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: C38D1(n= 0, 2)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
91.67 Units on a scale
Standard Deviation 11.79
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: EOT (n= 266, 246)
|
78.82 Units on a scale
Standard Deviation 24.54
|
78.52 Units on a scale
Standard Deviation 22.50
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: Pro Week 6 Pd(n= 0,1)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
83.33 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Cognitive: Survival FU 1 (n= 2, 1)
|
50.00 Units on a scale
Standard Deviation 47.14
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: Baseline (n= 390, 411)
|
75.83 Units on a scale
Standard Deviation 22.59
|
76.55 Units on a scale
Standard Deviation 21.77
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C2D1(n= 341, 363)
|
78.06 Units on a scale
Standard Deviation 22.63
|
79.47 Units on a scale
Standard Deviation 20.72
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C3D1(n= 256, 305)
|
79.70 Units on a scale
Standard Deviation 22.24
|
82.71 Units on a scale
Standard Deviation 17.45
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C4D1(n= 224, 280)
|
81.67 Units on a scale
Standard Deviation 20.36
|
83.69 Units on a scale
Standard Deviation 17.70
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C5D1(n= 166, 238)
|
80.52 Units on a scale
Standard Deviation 20.24
|
81.99 Units on a scale
Standard Deviation 19.22
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C6D1(n= 151, 224)
|
81.73 Units on a scale
Standard Deviation 20.50
|
82.70 Units on a scale
Standard Deviation 19.91
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C7D1(n= 87, 189)
|
81.42 Units on a scale
Standard Deviation 22.00
|
83.77 Units on a scale
Standard Deviation 17.71
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C8D1(n= 72, 171)
|
84.38 Units on a scale
Standard Deviation 18.66
|
83.63 Units on a scale
Standard Deviation 19.40
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C9D1(n= 50, 153)
|
86.00 Units on a scale
Standard Deviation 17.93
|
85.62 Units on a scale
Standard Deviation 18.72
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C10D1(n= 47, 146)
|
84.93 Units on a scale
Standard Deviation 17.69
|
84.13 Units on a scale
Standard Deviation 19.74
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C11D1(n= 36, 134)
|
89.12 Units on a scale
Standard Deviation 15.15
|
84.16 Units on a scale
Standard Deviation 18.14
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C12D1(n= 30, 132)
|
86.94 Units on a scale
Standard Deviation 14.79
|
84.34 Units on a scale
Standard Deviation 20.10
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C13D1(n= 18, 123)
|
89.35 Units on a scale
Standard Deviation 14.52
|
84.35 Units on a scale
Standard Deviation 19.75
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: Survival FU-1 (n= 2,1)
|
25.00 Units on a scale
Standard Deviation 35.36
|
33.33 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: Baseline (n= 390, 413)
|
73.27 Units on a scale
Standard Deviation 22.58
|
74.46 Units on a scale
Standard Deviation 20.66
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C2D1(n= 343, 369)
|
72.64 Units on a scale
Standard Deviation 22.00
|
71.70 Units on a scale
Standard Deviation 22.49
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C3D1(n= 255, 304)
|
74.98 Units on a scale
Standard Deviation 21.60
|
76.19 Units on a scale
Standard Deviation 19.48
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C4D1(n= 224, 277)
|
75.72 Units on a scale
Standard Deviation 19.05
|
76.79 Units on a scale
Standard Deviation 19.95
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C5D1(n= 167, 238)
|
77.30 Units on a scale
Standard Deviation 19.00
|
77.79 Units on a scale
Standard Deviation 19.89
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C6D1(n= 151, 225)
|
74.77 Units on a scale
Standard Deviation 19.26
|
78.93 Units on a scale
Standard Deviation 18.76
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C7D1(n= 88, 189)
|
77.61 Units on a scale
Standard Deviation 18.08
|
79.20 Units on a scale
Standard Deviation 18.42
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C8D1(n= 71, 170)
|
78.45 Units on a scale
Standard Deviation 17.72
|
78.87 Units on a scale
Standard Deviation 18.91
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C9D1(n= 50, 153)
|
79.07 Units on a scale
Standard Deviation 20.43
|
79.46 Units on a scale
Standard Deviation 18.75
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C10D1(n= 47, 146)
|
79.29 Units on a scale
Standard Deviation 19.96
|
79.41 Units on a scale
Standard Deviation 18.85
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C11D1(n= 37, 134)
|
81.44 Units on a scale
Standard Deviation 20.85
|
79.09 Units on a scale
Standard Deviation 20.50
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C12D1(n= 30, 132)
|
82.22 Units on a scale
Standard Deviation 15.69
|
79.72 Units on a scale
Standard Deviation 18.84
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C13D1(n= 19, 124)
|
87.37 Units on a scale
Standard Deviation 9.66
|
80.48 Units on a scale
Standard Deviation 19.33
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C14D1(n= 18, 121)
|
85.56 Units on a scale
Standard Deviation 9.50
|
80.33 Units on a scale
Standard Deviation 17.55
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C15D1(n= 16, 113)
|
86.25 Units on a scale
Standard Deviation 8.24
|
79.88 Units on a scale
Standard Deviation 18.64
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C16D1(n= 13, 109)
|
85.13 Units on a scale
Standard Deviation 9.49
|
78.82 Units on a scale
Standard Deviation 21.32
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C17D1(n= 11, 98)
|
84.24 Units on a scale
Standard Deviation 12.03
|
78.57 Units on a scale
Standard Deviation 20.89
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C18D1(n= 10, 92)
|
82.67 Units on a scale
Standard Deviation 13.03
|
79.64 Units on a scale
Standard Deviation 19.92
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C19D1(n= 9, 84)
|
87.41 Units on a scale
Standard Deviation 10.77
|
78.97 Units on a scale
Standard Deviation 20.48
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C20D1(n= 9, 80)
|
81.48 Units on a scale
Standard Deviation 18.19
|
79.19 Units on a scale
Standard Deviation 20.26
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C21D1(n= 9, 75)
|
87.41 Units on a scale
Standard Deviation 11.28
|
78.67 Units on a scale
Standard Deviation 20.68
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C22D1(n= 8, 69)
|
82.50 Units on a scale
Standard Deviation 19.82
|
82.51 Units on a scale
Standard Deviation 16.92
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C23D1(n= 8, 66)
|
85.00 Units on a scale
Standard Deviation 13.21
|
80.81 Units on a scale
Standard Deviation 17.56
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C24D1(n= 5, 64)
|
80.00 Units on a scale
Standard Deviation 18.26
|
81.41 Units on a scale
Standard Deviation 17.69
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C25D1(n= 3, 60)
|
82.22 Units on a scale
Standard Deviation 16.78
|
83.22 Units on a scale
Standard Deviation 16.67
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C26D1(n= 3, 55)
|
75.56 Units on a scale
Standard Deviation 3.85
|
80.12 Units on a scale
Standard Deviation 17.43
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C27D1(n= 2, 52)
|
76.67 Units on a scale
Standard Deviation 4.71
|
81.89 Units on a scale
Standard Deviation 16.90
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C28D1(n= 2, 49)
|
65.00 Units on a scale
Standard Deviation 21.21
|
84.15 Units on a scale
Standard Deviation 14.41
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C29D1(n= 2, 40)
|
56.67 Units on a scale
Standard Deviation 33.00
|
83.00 Units on a scale
Standard Deviation 14.87
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C30D1(n= 1, 31)
|
80.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
83.01 Units on a scale
Standard Deviation 15.67
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C31D1(n= 0, 24)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
78.61 Units on a scale
Standard Deviation 17.25
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C32D1(n= 0, 22)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
75.15 Units on a scale
Standard Deviation 18.42
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C33D1(n= 0, 16)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
77.92 Units on a scale
Standard Deviation 17.84
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C34D1(n= 0, 14)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
75.24 Units on a scale
Standard Deviation 19.47
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C35D1(n= 0, 12)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
73.89 Units on a scale
Standard Deviation 20.78
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C36D1(n= 0, 8)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
83.33 Units on a scale
Standard Deviation 17.46
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C37D1(n= 0, 5)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
74.67 Units on a scale
Standard Deviation 14.45
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: C38D1(n= 0, 2)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
86.67 Units on a scale
Standard Deviation 0.00
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: EOT(n= 267, 246)
|
63.59 Units on a scale
Standard Deviation 24.57
|
64.78 Units on a scale
Standard Deviation 26.47
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: Pro Week 6 Pd(n= 0, 1)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
46.67 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Physical: Survival FU-1 (n= 2, 1)
|
36.67 Units on a scale
Standard Deviation 51.85
|
46.67 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: Baseline (n=388, 413)
|
70.92 Units on a scale
Standard Deviation 30.68
|
73.61 Units on a scale
Standard Deviation 29.13
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C2D1 (n=339, 369)
|
69.91 Units on a scale
Standard Deviation 29.89
|
68.29 Units on a scale
Standard Deviation 31.50
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C3D1 (n=256, 304)
|
74.61 Units on a scale
Standard Deviation 27.21
|
75.27 Units on a scale
Standard Deviation 27.28
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C4D1 (n=224, 279)
|
73.36 Units on a scale
Standard Deviation 26.22
|
76.70 Units on a scale
Standard Deviation 25.27
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C5D1 (n=167, 238)
|
74.35 Units on a scale
Standard Deviation 25.00
|
76.05 Units on a scale
Standard Deviation 26.97
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C6D1 (n=151, 225)
|
73.62 Units on a scale
Standard Deviation 26.62
|
77.70 Units on a scale
Standard Deviation 26.78
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C7D1 (n=88, 190)
|
77.27 Units on a scale
Standard Deviation 23.19
|
79.04 Units on a scale
Standard Deviation 24.97
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C8D1 (n=72, 170)
|
73.61 Units on a scale
Standard Deviation 26.50
|
77.35 Units on a scale
Standard Deviation 25.22
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C9D1 (n=50, 153)
|
77.67 Units on a scale
Standard Deviation 24.42
|
79.30 Units on a scale
Standard Deviation 25.36
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C10D1 (n=47, 145)
|
78.72 Units on a scale
Standard Deviation 27.74
|
81.38 Units on a scale
Standard Deviation 24.34
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C11D1 (n=37, 134)
|
80.63 Units on a scale
Standard Deviation 24.69
|
78.61 Units on a scale
Standard Deviation 27.01
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C12D1 (n=30, 132)
|
81.11 Units on a scale
Standard Deviation 22.20
|
79.80 Units on a scale
Standard Deviation 25.97
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C13D1 (n=19, 124)
|
84.21 Units on a scale
Standard Deviation 18.82
|
79.44 Units on a scale
Standard Deviation 26.55
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C14D1 (n=18, 121)
|
78.70 Units on a scale
Standard Deviation 21.24
|
79.48 Units on a scale
Standard Deviation 24.98
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C15D1 (n=16, 113)
|
83.33 Units on a scale
Standard Deviation 14.91
|
79.20 Units on a scale
Standard Deviation 25.05
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C16D1 (n=13, 109)
|
85.90 Units on a scale
Standard Deviation 19.06
|
76.45 Units on a scale
Standard Deviation 27.89
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C17D1 (n=11, 98)
|
80.30 Units on a scale
Standard Deviation 20.84
|
76.02 Units on a scale
Standard Deviation 29.22
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C18D1 (n=10, 92)
|
80.00 Units on a scale
Standard Deviation 26.99
|
77.17 Units on a scale
Standard Deviation 27.59
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C19D1 (n=9, 84)
|
85.19 Units on a scale
Standard Deviation 22.74
|
78.17 Units on a scale
Standard Deviation 28.46
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C20D1 (n=9, 80)
|
79.63 Units on a scale
Standard Deviation 29.79
|
78.54 Units on a scale
Standard Deviation 26.01
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C21D1 (n=9, 75)
|
85.19 Units on a scale
Standard Deviation 15.47
|
77.33 Units on a scale
Standard Deviation 28.29
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C22D1 (n=8, 69)
|
79.17 Units on a scale
Standard Deviation 35.36
|
81.64 Units on a scale
Standard Deviation 26.68
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C23D1 (n=8, 66)
|
85.42 Units on a scale
Standard Deviation 20.77
|
80.30 Units on a scale
Standard Deviation 26.13
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C24D1 (n=5, 65)
|
70.00 Units on a scale
Standard Deviation 34.16
|
78.72 Units on a scale
Standard Deviation 26.92
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C25D1 (n=3, 60)
|
77.78 Units on a scale
Standard Deviation 38.49
|
79.44 Units on a scale
Standard Deviation 27.34
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C26D1 (n=3, 55)
|
83.33 Units on a scale
Standard Deviation 28.87
|
76.97 Units on a scale
Standard Deviation 27.31
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C27D1 (n=3, 52)
|
88.89 Units on a scale
Standard Deviation 19.24
|
80.77 Units on a scale
Standard Deviation 26.89
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C28D1 (n=1, 49)
|
100.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
82.99 Units on a scale
Standard Deviation 22.69
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C29D1 (n=2, 40)
|
66.67 Units on a scale
Standard Deviation 47.14
|
83.33 Units on a scale
Standard Deviation 24.75
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C30D1 (n=1, 31)
|
100.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
81.72 Units on a scale
Standard Deviation 24.10
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C31D1(n=0, 24)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
79.86 Units on a scale
Standard Deviation 25.53
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C32D1(n=0, 22)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
75.00 Units on a scale
Standard Deviation 27.58
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C33D1(n=0, 16)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
66.67 Units on a scale
Standard Deviation 34.43
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C34D1(n=0, 14)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
69.05 Units on a scale
Standard Deviation 33.88
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C35D1(n=0, 12)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
69.44 Units on a scale
Standard Deviation 32.44
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C36D1(n=0, 8)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
87.50 Units on a scale
Standard Deviation 17.25
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C37D1(n=0, 5)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
76.67 Units on a scale
Standard Deviation 22.36
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: C38D1(n=0, 2)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
100.00 Units on a scale
Standard Deviation 0.00
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: EOT(n=266, 246)
|
58.52 Units on a scale
Standard Deviation 32.99
|
60.03 Units on a scale
Standard Deviation 33.25
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: Pro Week 6 Pd (n=0, 1)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
66.67 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Role: Survival FU-1 (n=2,1)
|
33.33 Units on a scale
Standard Deviation 47.14
|
33.33 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: Baseline (n= 389, 411)
|
74.16 Units on a scale
Standard Deviation 26.92
|
77.41 Units on a scale
Standard Deviation 26.13
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C2D1(n= 340, 363)
|
74.51 Units on a scale
Standard Deviation 26.50
|
76.86 Units on a scale
Standard Deviation 26.25
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C3D1(n= 255, 305)
|
78.37 Units on a scale
Standard Deviation 25.30
|
81.15 Units on a scale
Standard Deviation 23.70
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C4D1(n= 223, 280)
|
79.60 Units on a scale
Standard Deviation 23.00
|
81.31 Units on a scale
Standard Deviation 24.15
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C5D1(n= 166, 238)
|
79.32 Units on a scale
Standard Deviation 22.26
|
82.00 Units on a scale
Standard Deviation 24.39
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C6D1(n= 151, 224)
|
78.15 Units on a scale
Standard Deviation 24.05
|
81.99 Units on a scale
Standard Deviation 23.80
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C7D1(n= 87, 189)
|
80.65 Units on a scale
Standard Deviation 22.57
|
82.80 Units on a scale
Standard Deviation 22.54
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C8D1(n= 72, 171)
|
81.94 Units on a scale
Standard Deviation 22.16
|
81.19 Units on a scale
Standard Deviation 23.95
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C9D1(n= 50, 153)
|
82.00 Units on a scale
Standard Deviation 22.80
|
83.77 Units on a scale
Standard Deviation 22.29
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C10D1(n= 47, 146)
|
81.21 Units on a scale
Standard Deviation 24.97
|
83.79 Units on a scale
Standard Deviation 22.99
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C11D1(n= 36, 134)
|
82.41 Units on a scale
Standard Deviation 26.11
|
81.47 Units on a scale
Standard Deviation 25.42
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C12D1(n= 30, 132)
|
86.67 Units on a scale
Standard Deviation 18.77
|
82.95 Units on a scale
Standard Deviation 24.58
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C13D1(n= 18, 124)
|
89.81 Units on a scale
Standard Deviation 15.27
|
84.27 Units on a scale
Standard Deviation 22.82
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C14D1(n= 17, 121)
|
86.27 Units on a scale
Standard Deviation 19.75
|
84.16 Units on a scale
Standard Deviation 22.55
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C15D1(n= 15, 113)
|
93.33 Units on a scale
Standard Deviation 13.80
|
83.92 Units on a scale
Standard Deviation 22.26
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C16D1(n= 12, 109)
|
84.72 Units on a scale
Standard Deviation 16.60
|
82.72 Units on a scale
Standard Deviation 24.73
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C17D1(n= 11, 98)
|
87.88 Units on a scale
Standard Deviation 16.82
|
82.99 Units on a scale
Standard Deviation 23.57
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C18D1(n= 10, 92)
|
86.67 Units on a scale
Standard Deviation 17.21
|
81.34 Units on a scale
Standard Deviation 24.06
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C19D1(n= 9, 84)
|
88.89 Units on a scale
Standard Deviation 16.67
|
81.94 Units on a scale
Standard Deviation 25.90
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C20D1(n= 9, 80)
|
81.48 Units on a scale
Standard Deviation 33.79
|
81.46 Units on a scale
Standard Deviation 24.73
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C21D1(n= 9, 75)
|
85.19 Units on a scale
Standard Deviation 24.22
|
78.67 Units on a scale
Standard Deviation 27.88
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C22D1(n= 8, 68)
|
85.42 Units on a scale
Standard Deviation 30.13
|
84.31 Units on a scale
Standard Deviation 25.41
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C23D1(n= 8, 66)
|
91.67 Units on a scale
Standard Deviation 15.43
|
80.56 Units on a scale
Standard Deviation 26.24
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C24D1(n= 5, 65)
|
80.00 Units on a scale
Standard Deviation 27.39
|
80.77 Units on a scale
Standard Deviation 25.38
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C25D1(n= 3, 60)
|
77.78 Units on a scale
Standard Deviation 38.49
|
81.39 Units on a scale
Standard Deviation 27.80
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C26D1(n= 3, 55)
|
77.78 Units on a scale
Standard Deviation 19.24
|
79.70 Units on a scale
Standard Deviation 27.53
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C27D1(n= 3, 52)
|
88.89 Units on a scale
Standard Deviation 19.24
|
82.05 Units on a scale
Standard Deviation 25.32
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C28D1(n= 1, 48)
|
100.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
84.03 Units on a scale
Standard Deviation 24.30
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C29D1(n= 2, 40)
|
50.00 Units on a scale
Standard Deviation 70.71
|
82.92 Units on a scale
Standard Deviation 24.60
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C30D1(n= 1, 31)
|
100.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
79.57 Units on a scale
Standard Deviation 27.79
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C31D1(n= 0, 24)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
79.17 Units on a scale
Standard Deviation 26.12
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C32D1(n= 0, 22)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
73.48 Units on a scale
Standard Deviation 30.71
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C33D1(n= 0, 16)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
73.96 Units on a scale
Standard Deviation 32.19
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C34D1(n= 0, 14)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
67.86 Units on a scale
Standard Deviation 34.88
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C35D1(n= 0, 12)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
70.83 Units on a scale
Standard Deviation 31.88
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C36D1(n= 0, 8)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
87.50 Units on a scale
Standard Deviation 17.25
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C37D1(n= 0, 5)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
80.00 Units on a scale
Standard Deviation 18.26
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: C38D1(n= 0, 2)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
100.00 Units on a scale
Standard Deviation 0.00
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: EOT(n= 264, 245)
|
69.51 Units on a scale
Standard Deviation 30.65
|
70.00 Units on a scale
Standard Deviation 30.05
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: Pro Week 6 Pd(n= 0, 1)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
66.67 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Social: Survival FU-1 (n= 2, 1)
|
83.33 Units on a scale
Standard Deviation 23.57
|
16.67 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C14D1(n= 17, 121)
|
86.27 Units on a scale
Standard Deviation 15.57
|
84.25 Units on a scale
Standard Deviation 19.11
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C15D1(n= 15, 113)
|
90.00 Units on a scale
Standard Deviation 14.16
|
83.87 Units on a scale
Standard Deviation 20.04
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C16D1(n= 12, 109)
|
88.89 Units on a scale
Standard Deviation 16.02
|
82.11 Units on a scale
Standard Deviation 22.59
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C17D1(n= 11, 98)
|
88.64 Units on a scale
Standard Deviation 17.59
|
83.25 Units on a scale
Standard Deviation 19.50
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C18D1(n= 10, 92)
|
87.50 Units on a scale
Standard Deviation 19.35
|
82.52 Units on a scale
Standard Deviation 21.11
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C19D1(n= 9, 84)
|
87.96 Units on a scale
Standard Deviation 19.14
|
81.42 Units on a scale
Standard Deviation 20.55
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C20D1(n=9, 80)
|
76.85 Units on a scale
Standard Deviation 34.30
|
83.19 Units on a scale
Standard Deviation 18.90
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C21D1(n= 9, 75)
|
83.33 Units on a scale
Standard Deviation 26.68
|
84.19 Units on a scale
Standard Deviation 17.58
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C22D1(n= 8, 68)
|
76.74 Units on a scale
Standard Deviation 32.60
|
86.03 Units on a scale
Standard Deviation 16.44
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C23D1(n= 8, 66)
|
89.58 Units on a scale
Standard Deviation 15.91
|
87.00 Units on a scale
Standard Deviation 17.55
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C24D1(n=5, 65)
|
78.33 Units on a scale
Standard Deviation 33.12
|
83.72 Units on a scale
Standard Deviation 19.18
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C25D1(n= 3, 60)
|
100.00 Units on a scale
Standard Deviation 0.00
|
83.66 Units on a scale
Standard Deviation 18.77
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C26D1(n= 3, 55)
|
86.11 Units on a scale
Standard Deviation 12.73
|
85.15 Units on a scale
Standard Deviation 19.69
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C27D1(n= 3, 52)
|
100.00 Units on a scale
Standard Deviation 0.00
|
86.38 Units on a scale
Standard Deviation 18.38
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C28D1(n= 1, 48)
|
100.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
86.92 Units on a scale
Standard Deviation 17.51
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C29D1(n= 2, 40)
|
50.00 Units on a scale
Standard Deviation 70.71
|
87.50 Units on a scale
Standard Deviation 16.45
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C30D1(n= 1, 31)
|
100.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
89.79 Units on a scale
Standard Deviation 15.62
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C31D1(n= 0, 24)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
85.76 Units on a scale
Standard Deviation 18.30
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C32D1(n= 0, 22)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
82.95 Units on a scale
Standard Deviation 20.81
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C33D1(n= 0, 16)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
81.25 Units on a scale
Standard Deviation 25.37
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C34D1(n= 0, 14)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
82.14 Units on a scale
Standard Deviation 25.29
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C35D1(n= 0, 12)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
83.33 Units on a scale
Standard Deviation 21.61
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C36D1(n= 0, 8)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
95.83 Units on a scale
Standard Deviation 11.78
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C37D1(n= 0, 5)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
90.00 Units on a scale
Standard Deviation 14.91
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: C38D1(n= 0, 2)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
83.33 Units on a scale
Standard Deviation 23.57
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: EOT (n= 265, 246)
|
73.78 Units on a scale
Standard Deviation 26.29
|
73.92 Units on a scale
Standard Deviation 23.74
|
|
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Emotional: Pro Week 6 Pd(n= 0,1)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
66.67 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
SECONDARY outcome
Timeframe: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)Population: The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
Outcome measures
| Measure |
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: Baseline (n= 387, 410)
|
60.55 Units on a scale
Standard Deviation 22.25
|
61.24 Units on a scale
Standard Deviation 22.31
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C2D1(n= 339, 361)
|
59.56 Units on a scale
Standard Deviation 22.15
|
58.93 Units on a scale
Standard Deviation 23.57
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C3D1(n= 255, 304)
|
64.64 Units on a scale
Standard Deviation 18.66
|
64.61 Units on a scale
Standard Deviation 20.74
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C4D1(n= 222, 279)
|
63.51 Units on a scale
Standard Deviation 20.67
|
65.11 Units on a scale
Standard Deviation 21.36
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C5D1(n= 166, 235)
|
64.01 Units on a scale
Standard Deviation 18.37
|
66.35 Units on a scale
Standard Deviation 19.84
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C6D1(n= 151, 223)
|
64.51 Units on a scale
Standard Deviation 19.59
|
65.73 Units on a scale
Standard Deviation 21.42
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C7D1(n= 87, 187)
|
64.85 Units on a scale
Standard Deviation 18.13
|
66.93 Units on a scale
Standard Deviation 19.61
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C8D1(n= 72, 169)
|
62.73 Units on a scale
Standard Deviation 20.22
|
67.36 Units on a scale
Standard Deviation 19.45
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C9D1(n= 50, 152)
|
67.17 Units on a scale
Standard Deviation 18.93
|
68.09 Units on a scale
Standard Deviation 19.46
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C10D1(n= 47, 145)
|
66.84 Units on a scale
Standard Deviation 18.67
|
69.37 Units on a scale
Standard Deviation 20.90
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C11D1(n= 36, 133)
|
69.68 Units on a scale
Standard Deviation 17.15
|
68.17 Units on a scale
Standard Deviation 21.24
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C12D1(n= 30, 131)
|
66.67 Units on a scale
Standard Deviation 18.05
|
68.32 Units on a scale
Standard Deviation 20.42
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C13D1(n= 18, 124)
|
69.91 Units on a scale
Standard Deviation 14.33
|
67.74 Units on a scale
Standard Deviation 22.52
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C14D1(n= 17, 120)
|
69.61 Units on a scale
Standard Deviation 14.71
|
67.01 Units on a scale
Standard Deviation 20.62
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C15D1(n= 15, 113)
|
69.44 Units on a scale
Standard Deviation 17.16
|
68.66 Units on a scale
Standard Deviation 20.21
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C16D1(n= 12, 109)
|
62.50 Units on a scale
Standard Deviation 15.69
|
67.97 Units on a scale
Standard Deviation 21.67
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C17D1(n= 10, 98)
|
61.67 Units on a scale
Standard Deviation 19.72
|
68.62 Units on a scale
Standard Deviation 19.84
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C18D1(n= 10, 92)
|
61.67 Units on a scale
Standard Deviation 21.23
|
68.57 Units on a scale
Standard Deviation 18.86
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C19D1(n= 9, 84)
|
65.74 Units on a scale
Standard Deviation 21.43
|
68.25 Units on a scale
Standard Deviation 20.10
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C20D1(n= 9, 80)
|
62.04 Units on a scale
Standard Deviation 26.72
|
68.12 Units on a scale
Standard Deviation 20.10
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C21D1(n= 9, 75)
|
60.19 Units on a scale
Standard Deviation 29.98
|
66.56 Units on a scale
Standard Deviation 21.55
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C22D1(n= 8, 68)
|
54.17 Units on a scale
Standard Deviation 24.80
|
73.28 Units on a scale
Standard Deviation 17.13
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C23D1(n= 8, 66)
|
62.50 Units on a scale
Standard Deviation 19.42
|
70.45 Units on a scale
Standard Deviation 18.09
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C24D1(n= 5, 65)
|
70.00 Units on a scale
Standard Deviation 27.39
|
69.36 Units on a scale
Standard Deviation 19.27
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C25D1(n= 3, 60)
|
66.67 Units on a scale
Standard Deviation 28.87
|
69.03 Units on a scale
Standard Deviation 19.23
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C26D1(n= 3, 55)
|
66.67 Units on a scale
Standard Deviation 28.87
|
68.64 Units on a scale
Standard Deviation 20.60
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C27D1(n= 3, 52)
|
66.67 Units on a scale
Standard Deviation 28.87
|
68.91 Units on a scale
Standard Deviation 21.84
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C28D1(n= 2, 48)
|
87.50 Units on a scale
Standard Deviation 17.68
|
71.87 Units on a scale
Standard Deviation 20.60
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C29D1(n= 2, 40)
|
91.67 Units on a scale
Standard Deviation 11.79
|
72.71 Units on a scale
Standard Deviation 20.06
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C30D1(n= 1, 30)
|
83.33 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
75.28 Units on a scale
Standard Deviation 18.63
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C31D1(n= 0, 24)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
71.53 Units on a scale
Standard Deviation 21.13
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C32D1(n= 0, 22)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
70.45 Units on a scale
Standard Deviation 20.21
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C33D1(n= 0,16)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
67.19 Units on a scale
Standard Deviation 27.30
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C34D1(n= 0, 14)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
68.45 Units on a scale
Standard Deviation 26.19
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C35D1(n= 0, 12)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
69.44 Units on a scale
Standard Deviation 26.43
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C36D1(n= 0, 8)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
80.21 Units on a scale
Standard Deviation 16.63
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C37D1(n= 0, 5)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
76.67 Units on a scale
Standard Deviation 19.00
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: C38D1(n= 0, 2)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
91.67 Units on a scale
Standard Deviation 11.79
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: EOT(n= 262, 245)
|
51.69 Units on a scale
Standard Deviation 24.02
|
52.82 Units on a scale
Standard Deviation 24.48
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: Pro Week 6 Pd(n= 0,1)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
50.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Global Health: Survival FU 1 (n= 2, 1)
|
58.33 Units on a scale
Standard Deviation 35.36
|
33.33 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
SECONDARY outcome
Timeframe: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)Population: The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
Outcome measures
| Measure |
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C27D1(n= 3, 52)
|
11.11 Units on a scale
Standard Deviation 19.24
|
22.65 Units on a scale
Standard Deviation 19.80
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: Baseline (n= 389, 413)
|
8.01 Units on a scale
Standard Deviation 16.34
|
7.59 Units on a scale
Standard Deviation 16.35
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C2D1(n= 342, 369)
|
11.50 Units on a scale
Standard Deviation 19.30
|
9.53 Units on a scale
Standard Deviation 17.25
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C3D1(n= 253, 305)
|
7.05 Units on a scale
Standard Deviation 15.06
|
7.27 Units on a scale
Standard Deviation 15.32
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C4D1(n= 223, 279)
|
7.40 Units on a scale
Standard Deviation 14.37
|
7.17 Units on a scale
Standard Deviation 15.50
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C5D1(n= 167, 238)
|
6.29 Units on a scale
Standard Deviation 12.49
|
6.44 Units on a scale
Standard Deviation 14.54
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C6D1(n= 151, 225)
|
6.40 Units on a scale
Standard Deviation 13.17
|
6.44 Units on a scale
Standard Deviation 15.16
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C7D1(n= 88, 190)
|
6.82 Units on a scale
Standard Deviation 13.28
|
5.61 Units on a scale
Standard Deviation 13.74
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C8D1(n= 72, 170)
|
6.02 Units on a scale
Standard Deviation 12.91
|
4.61 Units on a scale
Standard Deviation 10.57
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C9D1(n= 50, 153)
|
3.33 Units on a scale
Standard Deviation 8.91
|
2.83 Units on a scale
Standard Deviation 8.06
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C10D1(n= 47, 146)
|
2.48 Units on a scale
Standard Deviation 6.93
|
3.54 Units on a scale
Standard Deviation 10.02
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C11D1(n= 37, 134)
|
3.15 Units on a scale
Standard Deviation 6.62
|
3.23 Units on a scale
Standard Deviation 8.54
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C12D1(n= 30, 132)
|
3.89 Units on a scale
Standard Deviation 8.40
|
3.03 Units on a scale
Standard Deviation 7.66
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C13D1(n= 19, 124)
|
4.39 Units on a scale
Standard Deviation 9.37
|
3.36 Units on a scale
Standard Deviation 10.19
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C14D1(n= 18, 121)
|
4.63 Units on a scale
Standard Deviation 9.58
|
3.31 Units on a scale
Standard Deviation 9.03
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C15D1(n= 16, 113)
|
1.04 Units on a scale
Standard Deviation 4.17
|
3.83 Units on a scale
Standard Deviation 11.14
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C16D1(n= 13, 109)
|
5.13 Units on a scale
Standard Deviation 10.51
|
2.75 Units on a scale
Standard Deviation 8.64
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C17D1(n= 11, 98)
|
9.09 Units on a scale
Standard Deviation 13.67
|
2.55 Units on a scale
Standard Deviation 8.06
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C18D1(n= 10, 92)
|
6.67 Units on a scale
Standard Deviation 11.65
|
3.08 Units on a scale
Standard Deviation 8.88
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C19D1(n= 9, 84)
|
3.70 Units on a scale
Standard Deviation 7.35
|
4.17 Units on a scale
Standard Deviation 11.53
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C20D1(n= 9, 80)
|
5.56 Units on a scale
Standard Deviation 8.33
|
3.13 Units on a scale
Standard Deviation 11.28
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C21D1(n= 9, 75)
|
1.85 Units on a scale
Standard Deviation 5.56
|
4.89 Units on a scale
Standard Deviation 13.08
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C22D1(n= 8, 69)
|
6.25 Units on a scale
Standard Deviation 8.63
|
1.93 Units on a scale
Standard Deviation 7.31
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C23D1(n= 8, 66)
|
6.25 Units on a scale
Standard Deviation 12.40
|
2.53 Units on a scale
Standard Deviation 6.69
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C24D1(n= 5, 64)
|
0.00 Units on a scale
Standard Deviation 0.00
|
2.34 Units on a scale
Standard Deviation 7.19
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C25D1(n= 3, 60)
|
0.00 Units on a scale
Standard Deviation 0.00
|
1.94 Units on a scale
Standard Deviation 6.21
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C26D1(n= 3, 55)
|
0.00 Units on a scale
Standard Deviation 0.00
|
2.73 Units on a scale
Standard Deviation 8.34
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C27D1(n= 3, 52)
|
0.00 Units on a scale
Standard Deviation 0.00
|
2.24 Units on a scale
Standard Deviation 6.62
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C28D1(n= 1, 49)
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
1.02 Units on a scale
Standard Deviation 4.04
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C29D1(n= 2, 40)
|
33.33 Units on a scale
Standard Deviation 47.14
|
1.67 Units on a scale
Standard Deviation 5.06
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C30D1(n= 1, 31)
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
1.61 Units on a scale
Standard Deviation 5.01
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C31D1(n= 0, 24)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
2.08 Units on a scale
Standard Deviation 5.63
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C32D1(n= 0, 22)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
1.52 Units on a scale
Standard Deviation 4.90
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C33D1(n= 0,16)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
1.04 Units on a scale
Standard Deviation 4.17
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C34D1(n= 0, 14)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
2.38 Units on a scale
Standard Deviation 8.91
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C35D1(n= 0, 12)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
1.39 Units on a scale
Standard Deviation 4.81
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C36D1(n= 0, 8)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
4.17 Units on a scale
Standard Deviation 11.78
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C37D1(n= 0, 5)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
6.67 Units on a scale
Standard Deviation 9.13
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: C38D1(n= 0, 2)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
0.00 Units on a scale
Standard Deviation 0.00
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: EOT(n= 266, 245)
|
11.65 Units on a scale
Standard Deviation 20.11
|
10.61 Units on a scale
Standard Deviation 17.62
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: Pro Week 6 Pd(n= 0,1)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
16.67 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Nausea/Vomiting: Survival FU 1 (n= 2, 1)
|
50.00 Units on a scale
Standard Deviation 70.71
|
66.67 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: Baseline (n= 390, 413)
|
29.70 Units on a scale
Standard Deviation 29.45
|
29.98 Units on a scale
Standard Deviation 29.72
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C2D1(n= 343, 368)
|
28.43 Units on a scale
Standard Deviation 27.24
|
29.30 Units on a scale
Standard Deviation 29.03
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C3D1(n= 256, 305)
|
22.59 Units on a scale
Standard Deviation 24.93
|
24.15 Units on a scale
Standard Deviation 27.50
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C4D1(n= 224, 280)
|
21.65 Units on a scale
Standard Deviation 24.48
|
23.75 Units on a scale
Standard Deviation 25.84
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C5D1(n= 167, 239)
|
20.96 Units on a scale
Standard Deviation 22.55
|
23.22 Units on a scale
Standard Deviation 25.41
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C6D1(n= 151, 225)
|
22.41 Units on a scale
Standard Deviation 21.95
|
21.63 Units on a scale
Standard Deviation 24.68
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C7D1(n= 88, 190)
|
21.59 Units on a scale
Standard Deviation 22.34
|
21.58 Units on a scale
Standard Deviation 25.30
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C8D1(n= 72, 171)
|
23.38 Units on a scale
Standard Deviation 22.49
|
22.03 Units on a scale
Standard Deviation 24.36
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C9D1(n= 50, 153)
|
16.33 Units on a scale
Standard Deviation 20.89
|
19.28 Units on a scale
Standard Deviation 23.50
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C10D1(n= 47, 146)
|
14.54 Units on a scale
Standard Deviation 17.93
|
21.00 Units on a scale
Standard Deviation 24.61
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C11D1(n= 37, 134)
|
13.96 Units on a scale
Standard Deviation 22.05
|
21.27 Units on a scale
Standard Deviation 26.60
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C12D1(n= 30, 132)
|
13.33 Units on a scale
Standard Deviation 21.17
|
18.69 Units on a scale
Standard Deviation 24.71
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C13D1(n= 19, 124)
|
16.67 Units on a scale
Standard Deviation 25.46
|
17.74 Units on a scale
Standard Deviation 21.23
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C14D1(n= 18, 120)
|
12.04 Units on a scale
Standard Deviation 15.97
|
17.64 Units on a scale
Standard Deviation 22.17
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C15D1(n= 16, 113)
|
10.42 Units on a scale
Standard Deviation 17.08
|
17.40 Units on a scale
Standard Deviation 22.86
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C16D1(n= 13, 109)
|
21.79 Units on a scale
Standard Deviation 21.93
|
20.64 Units on a scale
Standard Deviation 25.25
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C17D1(n= 11, 98)
|
16.67 Units on a scale
Standard Deviation 19.72
|
20.41 Units on a scale
Standard Deviation 25.39
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C18D1(n= 10, 92)
|
11.67 Units on a scale
Standard Deviation 22.29
|
20.83 Units on a scale
Standard Deviation 24.54
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C19D1(n= 9, 84)
|
14.81 Units on a scale
Standard Deviation 22.74
|
22.42 Units on a scale
Standard Deviation 28.16
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C20D1(n=9, 80)
|
27.78 Units on a scale
Standard Deviation 31.18
|
20.00 Units on a scale
Standard Deviation 23.78
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C21D1(n= 9, 75)
|
14.81 Units on a scale
Standard Deviation 17.57
|
19.78 Units on a scale
Standard Deviation 25.95
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C22D1(n= 8, 69)
|
18.75 Units on a scale
Standard Deviation 20.77
|
15.22 Units on a scale
Standard Deviation 19.75
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C23D1(n= 8, 66)
|
14.58 Units on a scale
Standard Deviation 27.37
|
16.92 Units on a scale
Standard Deviation 23.11
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C24D1(n=5, 64)
|
30.00 Units on a scale
Standard Deviation 36.13
|
20.05 Units on a scale
Standard Deviation 25.05
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C25D1(n= 3, 60)
|
16.67 Units on a scale
Standard Deviation 28.87
|
18.33 Units on a scale
Standard Deviation 22.90
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C26D1(n= 3, 55)
|
22.22 Units on a scale
Standard Deviation 19.24
|
16.36 Units on a scale
Standard Deviation 21.87
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C27D1(n= 3, 52)
|
11.11 Units on a scale
Standard Deviation 19.24
|
15.06 Units on a scale
Standard Deviation 20.41
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C28D1(n= 1, 49)
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
14.29 Units on a scale
Standard Deviation 18.63
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C29D1(n= 2, 40)
|
41.67 Units on a scale
Standard Deviation 58.93
|
13.75 Units on a scale
Standard Deviation 18.06
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C30D1(n= 1, 31)
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
15.05 Units on a scale
Standard Deviation 21.24
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C31D1(n= 0, 24)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
14.58 Units on a scale
Standard Deviation 21.03
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C32D1(n= 0, 22)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
16.67 Units on a scale
Standard Deviation 24.67
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C33D1(n= 0, 16)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
20.83 Units on a scale
Standard Deviation 27.55
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C34D1(n= 0, 14)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
26.19 Units on a scale
Standard Deviation 27.51
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C35D1(n= 0, 12)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
22.22 Units on a scale
Standard Deviation 25.95
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C36D1(n= 0, 8)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
22.92 Units on a scale
Standard Deviation 34.43
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C37D1(n= 0, 5)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
30.00 Units on a scale
Standard Deviation 34.16
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: C38D1(n= 0, 2)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
0.00 Units on a scale
Standard Deviation 0.00
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: EOT (n= 267, 247)
|
32.21 Units on a scale
Standard Deviation 30.36
|
35.43 Units on a scale
Standard Deviation 31.22
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: Pro Week 6 Pd(n= 0,1)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
16.67 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Pain: Survival FU-1 (n= 2,1)
|
66.67 Units on a scale
Standard Deviation 47.14
|
83.33 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: Baseline (n= 390, 413)
|
37.59 Units on a scale
Standard Deviation 25.69
|
36.21 Units on a scale
Standard Deviation 23.92
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C2D1(n= 343, 369)
|
40.52 Units on a scale
Standard Deviation 25.68
|
39.78 Units on a scale
Standard Deviation 26.17
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C3D1(n= 256, 304)
|
35.29 Units on a scale
Standard Deviation 23.97
|
33.90 Units on a scale
Standard Deviation 23.75
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C4D1(n= 224, 278)
|
35.59 Units on a scale
Standard Deviation 23.10
|
30.72 Units on a scale
Standard Deviation 22.57
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C5D1(n= 167, 238)
|
36.03 Units on a scale
Standard Deviation 22.40
|
30.95 Units on a scale
Standard Deviation 24.13
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C6D1(n= 151, 225)
|
36.28 Units on a scale
Standard Deviation 23.40
|
28.89 Units on a scale
Standard Deviation 22.66
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C7D1(n= 88, 190)
|
34.34 Units on a scale
Standard Deviation 23.02
|
28.33 Units on a scale
Standard Deviation 22.15
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C8D1(n= 72, 170)
|
30.86 Units on a scale
Standard Deviation 24.12
|
27.97 Units on a scale
Standard Deviation 21.56
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C9D1(n= 50, 153)
|
28.67 Units on a scale
Standard Deviation 23.45
|
25.78 Units on a scale
Standard Deviation 21.39
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C10D1(n= 47, 145)
|
29.31 Units on a scale
Standard Deviation 25.21
|
26.32 Units on a scale
Standard Deviation 22.27
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C11D1(n= 37, 134)
|
27.63 Units on a scale
Standard Deviation 25.07
|
25.62 Units on a scale
Standard Deviation 23.05
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C12D1(n= 30, 132)
|
28.89 Units on a scale
Standard Deviation 23.99
|
26.60 Units on a scale
Standard Deviation 23.37
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C13D1(n= 19, 124)
|
22.22 Units on a scale
Standard Deviation 20.29
|
27.51 Units on a scale
Standard Deviation 22.73
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C14D1(n= 18, 121)
|
21.60 Units on a scale
Standard Deviation 16.82
|
26.31 Units on a scale
Standard Deviation 23.13
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C15D1(n= 16, 112)
|
20.14 Units on a scale
Standard Deviation 18.24
|
27.73 Units on a scale
Standard Deviation 22.56
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C16D1(n= 13, 109)
|
21.79 Units on a scale
Standard Deviation 17.64
|
27.22 Units on a scale
Standard Deviation 23.35
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C17D1(n= 11, 98)
|
22.22 Units on a scale
Standard Deviation 12.17
|
27.21 Units on a scale
Standard Deviation 23.56
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C18D1(n= 10, 92)
|
26.67 Units on a scale
Standard Deviation 17.53
|
27.29 Units on a scale
Standard Deviation 24.18
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C19D1(n= 9, 84)
|
22.22 Units on a scale
Standard Deviation 14.70
|
27.65 Units on a scale
Standard Deviation 22.85
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C20D1(n= 9, 80)
|
32.10 Units on a scale
Standard Deviation 30.15
|
25.21 Units on a scale
Standard Deviation 23.47
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C21D1(n= 9, 75)
|
28.39 Units on a scale
Standard Deviation 18.52
|
26.44 Units on a scale
Standard Deviation 23.66
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C22D1(n= 8, 69)
|
33.33 Units on a scale
Standard Deviation 29.10
|
22.38 Units on a scale
Standard Deviation 21.77
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C23D1(n= 8, 66)
|
25.00 Units on a scale
Standard Deviation 24.31
|
24.16 Units on a scale
Standard Deviation 20.59
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C24D1(n= 5, 64)
|
31.11 Units on a scale
Standard Deviation 40.37
|
23.78 Units on a scale
Standard Deviation 18.87
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C25D1(n= 3, 60)
|
11.11 Units on a scale
Standard Deviation 19.24
|
23.89 Units on a scale
Standard Deviation 20.94
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C26D1(n= 3, 55)
|
18.52 Units on a scale
Standard Deviation 16.97
|
28.69 Units on a scale
Standard Deviation 24.54
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C28D1(n= 1, 49)
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
22.34 Units on a scale
Standard Deviation 18.23
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C29D1(n= 2, 40)
|
44.44 Units on a scale
Standard Deviation 47.14
|
21.11 Units on a scale
Standard Deviation 18.63
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C30D1(n= 1, 31)
|
22.22 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
23.66 Units on a scale
Standard Deviation 20.23
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C31D1(n= 0, 24)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
23.15 Units on a scale
Standard Deviation 20.96
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C32D1(n= 0, 22)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
25.25 Units on a scale
Standard Deviation 20.63
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C33D1(n= 0, 16)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
29.86 Units on a scale
Standard Deviation 26.52
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C34D1(n= 0, 14)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
31.75 Units on a scale
Standard Deviation 24.21
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C35D1(n= 0, 12)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
25.00 Units on a scale
Standard Deviation 21.25
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C36D1(n= 0, 8)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
16.67 Units on a scale
Standard Deviation 15.71
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C37D1(n= 0, 5)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
24.44 Units on a scale
Standard Deviation 16.48
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: C38D1(n= 0, 2)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
16.67 Units on a scale
Standard Deviation 7.86
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: EOT(n= 267, 246)
|
47.50 Units on a scale
Standard Deviation 26.72
|
43.07 Units on a scale
Standard Deviation 28.15
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: Pro Week 6 Pd(n= 0, 1)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
44.44 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Fatigue: Survival FU-1 (n= 2, 1)
|
83.33 Units on a scale
Standard Deviation 23.57
|
88.89 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
SECONDARY outcome
Timeframe: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)Population: The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for alopecia.
Outcome measures
| Measure |
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: Baseline (n= 384, 405)
|
13.89 Units on a scale
Standard Deviation 27.95
|
14.32 Units on a scale
Standard Deviation 29.07
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C2D1(n= 332, 357)
|
60.44 Units on a scale
Standard Deviation 36.66
|
6.63 Units on a scale
Standard Deviation 16.84
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C3D1(n= 248, 300)
|
56.72 Units on a scale
Standard Deviation 35.86
|
7.44 Units on a scale
Standard Deviation 18.89
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C4D1(n= 219, 270)
|
52.36 Units on a scale
Standard Deviation 35.24
|
7.41 Units on a scale
Standard Deviation 19.14
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C5D1(n= 163, 234)
|
56.65 Units on a scale
Standard Deviation 37.25
|
6.41 Units on a scale
Standard Deviation 16.68
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C6D1(n= 147, 220)
|
54.42 Units on a scale
Standard Deviation 37.64
|
7.88 Units on a scale
Standard Deviation 19.34
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C7D1(n= 87, 186)
|
52.11 Units on a scale
Standard Deviation 39.28
|
5.91 Units on a scale
Standard Deviation 16.10
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C8D1(n= 70, 166)
|
48.57 Units on a scale
Standard Deviation 37.94
|
6.63 Units on a scale
Standard Deviation 17.68
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C9D1(n= 47, 150)
|
48.23 Units on a scale
Standard Deviation 39.81
|
5.11 Units on a scale
Standard Deviation 14.83
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C10D1(n= 45, 142)
|
49.63 Units on a scale
Standard Deviation 39.96
|
3.76 Units on a scale
Standard Deviation 13.23
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C11D1(n= 36, 130)
|
47.22 Units on a scale
Standard Deviation 45.34
|
3.08 Units on a scale
Standard Deviation 11.33
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C12D1(n= 29, 129)
|
36.78 Units on a scale
Standard Deviation 43.04
|
4.91 Units on a scale
Standard Deviation 13.88
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C13D1(n= 19, 121)
|
42.11 Units on a scale
Standard Deviation 41.34
|
6.06 Units on a scale
Standard Deviation 15.52
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C14D1(n= 18, 119)
|
29.63 Units on a scale
Standard Deviation 35.95
|
5.60 Units on a scale
Standard Deviation 14.60
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C15D1(n= 16, 110)
|
33.33 Units on a scale
Standard Deviation 34.43
|
7.27 Units on a scale
Standard Deviation 17.12
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C16D1(n= 12, 105)
|
27.78 Units on a scale
Standard Deviation 31.25
|
7.30 Units on a scale
Standard Deviation 17.89
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C17D1(n= 11, 95)
|
21.21 Units on a scale
Standard Deviation 30.81
|
9.47 Units on a scale
Standard Deviation 19.85
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C18D1(n= 9, 90)
|
22.22 Units on a scale
Standard Deviation 33.33
|
8.89 Units on a scale
Standard Deviation 17.16
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C19D1(n= 8, 81)
|
25.00 Units on a scale
Standard Deviation 34.50
|
10.29 Units on a scale
Standard Deviation 18.74
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C20D1(n= 9, 78)
|
44.44 Units on a scale
Standard Deviation 44.10
|
8.55 Units on a scale
Standard Deviation 15.60
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C21D1(n= 9, 73)
|
22.22 Units on a scale
Standard Deviation 33.33
|
9.59 Units on a scale
Standard Deviation 16.18
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C22D1(n= 7, 67)
|
9.52 Units on a scale
Standard Deviation 16.26
|
9.45 Units on a scale
Standard Deviation 16.21
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C23D1(n= 8, 64)
|
29.17 Units on a scale
Standard Deviation 37.53
|
11.46 Units on a scale
Standard Deviation 18.99
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C24D1(n= 5, 62)
|
13.33 Units on a scale
Standard Deviation 18.26
|
8.06 Units on a scale
Standard Deviation 15.61
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C25D1(n= 2, 58)
|
0.00 Units on a scale
Standard Deviation 0.00
|
9.77 Units on a scale
Standard Deviation 16.53
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C26D1(n= 2, 53)
|
0.00 Units on a scale
Standard Deviation 0.00
|
9.43 Units on a scale
Standard Deviation 16.51
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C27D1(n= 3, 50)
|
33.33 Units on a scale
Standard Deviation 57.74
|
9.33 Units on a scale
Standard Deviation 16.55
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C28D1(n= 2, 46)
|
0.00 Units on a scale
Standard Deviation 0.00
|
6.52 Units on a scale
Standard Deviation 15.10
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C29D1(n= 2, 38)
|
0.00 Units on a scale
Standard Deviation 0.00
|
8.77 Units on a scale
Standard Deviation 20.04
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C30D1(n= 1, 31)
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
10.75 Units on a scale
Standard Deviation 19.98
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C31D1(n= 0, 24)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
9.72 Units on a scale
Standard Deviation 20.80
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C32D1(n= 0, 23)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
7.25 Units on a scale
Standard Deviation 19.99
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C33D1(n= 0,16)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
8.33 Units on a scale
Standard Deviation 22.77
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C34D1(n= 0, 14)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
9.52 Units on a scale
Standard Deviation 20.38
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C35D1(n= 0, 11)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
6.06 Units on a scale
Standard Deviation 13.48
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C36D1(n= 0, 8)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
4.17 Units on a scale
Standard Deviation 11.78
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C37D1(n= 0, 5)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
6.67 Units on a scale
Standard Deviation 14.91
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: C38D1(n= 0, 2)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
0.00 Units on a scale
Standard Deviation 0.00
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: EOT(n= 261, 243)
|
53.51 Units on a scale
Standard Deviation 38.91
|
6.58 Units on a scale
Standard Deviation 17.48
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: Pro Week 6 Pd(n= 0,1)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
100.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Alopecia: Survival FU 1 (n= 2, 1)
|
100.00 Units on a scale
Standard Deviation 0.00
|
66.67 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
SECONDARY outcome
Timeframe: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)Population: The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for coughing.
Outcome measures
| Measure |
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: Baseline (n= 383, 406)
|
38.73 Units on a scale
Standard Deviation 29.64
|
37.27 Units on a scale
Standard Deviation 27.23
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C2D1(n= 333, 360)
|
36.54 Units on a scale
Standard Deviation 28.04
|
37.50 Units on a scale
Standard Deviation 28.33
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C3D1(n= 250, 298)
|
33.73 Units on a scale
Standard Deviation 27.46
|
33.89 Units on a scale
Standard Deviation 24.99
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C4D1(n= 219, 272)
|
31.35 Units on a scale
Standard Deviation 24.13
|
32.48 Units on a scale
Standard Deviation 25.52
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C5D1(n= 164, 235)
|
32.72 Units on a scale
Standard Deviation 23.49
|
31.35 Units on a scale
Standard Deviation 25.52
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C6D1(n= 147, 219)
|
31.75 Units on a scale
Standard Deviation 24.78
|
31.05 Units on a scale
Standard Deviation 24.73
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C7D1(n= 87, 185)
|
32.95 Units on a scale
Standard Deviation 24.64
|
30.99 Units on a scale
Standard Deviation 25.07
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C8D1(n= 69, 166)
|
30.43 Units on a scale
Standard Deviation 28.43
|
29.12 Units on a scale
Standard Deviation 25.73
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C9D1(n= 50, 150)
|
24.67 Units on a scale
Standard Deviation 17.57
|
29.11 Units on a scale
Standard Deviation 24.52
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C10D1(n= 47, 140)
|
23.40 Units on a scale
Standard Deviation 19.55
|
27.86 Units on a scale
Standard Deviation 22.83
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C11D1(n= 37, 129)
|
21.62 Units on a scale
Standard Deviation 19.59
|
27.39 Units on a scale
Standard Deviation 23.37
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C12D1(n= 30, 129)
|
20.00 Units on a scale
Standard Deviation 18.77
|
25.06 Units on a scale
Standard Deviation 23.95
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C13D1(n= 19, 121)
|
15.79 Units on a scale
Standard Deviation 17.10
|
24.79 Units on a scale
Standard Deviation 23.78
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C14D1(n= 18, 119)
|
16.67 Units on a scale
Standard Deviation 17.15
|
24.37 Units on a scale
Standard Deviation 22.42
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C15D1(n= 16, 110)
|
12.50 Units on a scale
Standard Deviation 16.67
|
25.76 Units on a scale
Standard Deviation 23.31
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C16D1(n= 13, 106)
|
20.51 Units on a scale
Standard Deviation 21.68
|
24.53 Units on a scale
Standard Deviation 22.21
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C17D1(n= 11, 94)
|
21.21 Units on a scale
Standard Deviation 16.82
|
24.82 Units on a scale
Standard Deviation 23.92
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C18D1(n= 10, 90)
|
26.67 Units on a scale
Standard Deviation 21.08
|
26.30 Units on a scale
Standard Deviation 24.22
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C19D1(n= 9, 82)
|
22.22 Units on a scale
Standard Deviation 16.67
|
25.61 Units on a scale
Standard Deviation 26.86
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C20D1(n= 9, 78)
|
25.93 Units on a scale
Standard Deviation 14.70
|
28.21 Units on a scale
Standard Deviation 26.36
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C21D1(n= 9, 73)
|
22.22 Units on a scale
Standard Deviation 16.67
|
28.77 Units on a scale
Standard Deviation 27.95
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C22D1(n= 8, 67)
|
25.00 Units on a scale
Standard Deviation 38.83
|
22.89 Units on a scale
Standard Deviation 23.36
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C23D1(n= 8, 64)
|
20.83 Units on a scale
Standard Deviation 17.25
|
23.44 Units on a scale
Standard Deviation 26.35
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C24D1(n= 5, 62)
|
26.67 Units on a scale
Standard Deviation 14.91
|
24.73 Units on a scale
Standard Deviation 23.33
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C25D1(n= 3, 58)
|
33.33 Units on a scale
Standard Deviation 0.00
|
25.86 Units on a scale
Standard Deviation 23.40
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C26D1(n= 3, 53)
|
44.44 Units on a scale
Standard Deviation 19.25
|
26.41 Units on a scale
Standard Deviation 24.77
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C27D1(n= 3, 50)
|
11.11 Units on a scale
Standard Deviation 19.24
|
24.67 Units on a scale
Standard Deviation 22.14
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C28D1(n= 2, 46)
|
16.67 Units on a scale
Standard Deviation 23.57
|
20.29 Units on a scale
Standard Deviation 20.46
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C29D1(n= 2, 38)
|
16.67 Units on a scale
Standard Deviation 23.57
|
19.30 Units on a scale
Standard Deviation 22.77
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C30D1(n= 1, 31)
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
18.28 Units on a scale
Standard Deviation 20.80
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C31D1(n= 0, 24)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
23.61 Units on a scale
Standard Deviation 25.02
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C32D1(n= 0, 23)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
26.09 Units on a scale
Standard Deviation 19.99
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C33D1(n= 0,16)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
27.08 Units on a scale
Standard Deviation 32.70
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C34D1(n= 0, 14)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
26.19 Units on a scale
Standard Deviation 29.75
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C35D1(n= 0, 11)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
21.21 Units on a scale
Standard Deviation 22.47
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C36D1(n= 0, 8)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
25.00 Units on a scale
Standard Deviation 15.43
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C37D1(n= 0, 5)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
26.67 Units on a scale
Standard Deviation 14.91
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: C38D1(n= 0, 2)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
33.33 Units on a scale
Standard Deviation 0.00
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: EOT(n= 262, 246)
|
35.75 Units on a scale
Standard Deviation 27.03
|
38.48 Units on a scale
Standard Deviation 26.95
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: Pro Week 6 Pd(n= 0,1)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
33.33 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ-LC13 Questionnaire Score: Coughing
Coughing: Survival FU 1 (n= 2, 1)
|
50.00 Units on a scale
Standard Deviation 23.57
|
33.33 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
SECONDARY outcome
Timeframe: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)Population: The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for dysphagia.
Outcome measures
| Measure |
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C7D1(n= 87, 187)
|
4.21 Units on a scale
Standard Deviation 11.14
|
5.70 Units on a scale
Standard Deviation 15.17
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C8D1(n=70, 167)
|
5.71 Units on a scale
Standard Deviation 12.65
|
4.79 Units on a scale
Standard Deviation 12.82
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C9D1(n= 50, 151)
|
1.33 Units on a scale
Standard Deviation 6.60
|
4.64 Units on a scale
Standard Deviation 14.42
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C10D1(n= 47, 143)
|
1.42 Units on a scale
Standard Deviation 6.80
|
5.36 Units on a scale
Standard Deviation 15.14
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C11D1(n= 37, 130)
|
1.80 Units on a scale
Standard Deviation 7.64
|
2.82 Units on a scale
Standard Deviation 11.01
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C12D1(n= 29, 129)
|
2.30 Units on a scale
Standard Deviation 8.60
|
3.88 Units on a scale
Standard Deviation 12.93
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C13D1(n= 19, 121)
|
0.00 Units on a scale
Standard Deviation 0.00
|
3.86 Units on a scale
Standard Deviation 11.54
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: Baseline (n= 387, 406)
|
6.20 Units on a scale
Standard Deviation 17.52
|
5.09 Units on a scale
Standard Deviation 15.05
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C2D1(n= 336, 358)
|
10.22 Units on a scale
Standard Deviation 21.50
|
6.42 Units on a scale
Standard Deviation 15.75
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C3D1(n= 251, 301)
|
9.16 Units on a scale
Standard Deviation 20.87
|
5.43 Units on a scale
Standard Deviation 14.53
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C4D1(n= 217, 272)
|
8.60 Units on a scale
Standard Deviation 19.45
|
5.88 Units on a scale
Standard Deviation 16.39
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C5D1(n= 163, 236)
|
6.75 Units on a scale
Standard Deviation 16.63
|
6.64 Units on a scale
Standard Deviation 16.79
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C6D1(n= 147, 219)
|
6.80 Units on a scale
Standard Deviation 15.58
|
4.72 Units on a scale
Standard Deviation 13.28
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C14D1(n= 18, 119)
|
5.56 Units on a scale
Standard Deviation 12.78
|
5.04 Units on a scale
Standard Deviation 13.47
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C15D1(n= 16, 110)
|
0.00 Units on a scale
Standard Deviation 0.00
|
3.33 Units on a scale
Standard Deviation 11.01
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C16D1(n= 13, 106)
|
0.00 Units on a scale
Standard Deviation 0.00
|
3.77 Units on a scale
Standard Deviation 12.45
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C17D1(n= 11, 95)
|
3.03 Units on a scale
Standard Deviation 10.05
|
3.86 Units on a scale
Standard Deviation 13.63
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C18D1(n= 10, 90)
|
0.00 Units on a scale
Standard Deviation 0.00
|
4.44 Units on a scale
Standard Deviation 15.96
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C19D1(n= 9, 82)
|
3.70 Units on a scale
Standard Deviation 11.11
|
5.28 Units on a scale
Standard Deviation 15.24
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C20D1(n= 9, 78)
|
0.00 Units on a scale
Standard Deviation 0.00
|
4.70 Units on a scale
Standard Deviation 12.85
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C21D1(n= 9, 73)
|
0.00 Units on a scale
Standard Deviation 0.00
|
5.02 Units on a scale
Standard Deviation 15.39
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C22D1(n= 8, 67)
|
0.00 Units on a scale
Standard Deviation 0.00
|
2.99 Units on a scale
Standard Deviation 11.21
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C23D1(n= 8, 64)
|
0.00 Units on a scale
Standard Deviation 0.00
|
3.65 Units on a scale
Standard Deviation 12.05
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C24D1(n= 5, 62)
|
0.00 Units on a scale
Standard Deviation 0.00
|
4.84 Units on a scale
Standard Deviation 15.79
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C25D1(n= 3, 58)
|
0.00 Units on a scale
Standard Deviation 0.00
|
4.02 Units on a scale
Standard Deviation 15.39
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C26D1(n= 3, 53)
|
0.00 Units on a scale
Standard Deviation 0.00
|
4.40 Units on a scale
Standard Deviation 13.14
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C27D1(n= 3, 50)
|
0.00 Units on a scale
Standard Deviation 0.00
|
2.67 Units on a scale
Standard Deviation 11.35
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C28D1(n= 2, 46)
|
0.00 Units on a scale
Standard Deviation 0.00
|
4.35 Units on a scale
Standard Deviation 15.09
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C29D1(n= 2, 38)
|
0.00 Units on a scale
Standard Deviation 0.00
|
4.39 Units on a scale
Standard Deviation 13.80
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C30D1(n= 1, 31)
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
5.38 Units on a scale
Standard Deviation 15.15
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C31D1(n= 0, 24)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
5.56 Units on a scale
Standard Deviation 21.23
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C32D1(n= 0, 23)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
7.25 Units on a scale
Standard Deviation 17.28
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C33D1(n= 0,16)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
6.25 Units on a scale
Standard Deviation 13.44
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C34D1(n= 0, 14)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
9.52 Units on a scale
Standard Deviation 20.38
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C35D1(n= 0, 11)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
3.03 Units on a scale
Standard Deviation 10.05
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C36D1(n= 0, 8)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
4.17 Units on a scale
Standard Deviation 11.78
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C37D1(n= 0, 5)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
6.67 Units on a scale
Standard Deviation 14.91
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: C38D1(n= 0, 2)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
0.00 Units on a scale
Standard Deviation 0.00
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: EOT(n= 264, 245)
|
10.23 Units on a scale
Standard Deviation 20.77
|
8.98 Units on a scale
Standard Deviation 18.87
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: Pro Week 6 Pd(n= 0,1)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Dysphagia: Survival FU 1 (n= 2, 1)
|
0.00 Units on a scale
Standard Deviation 0.00
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
SECONDARY outcome
Timeframe: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)Population: The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for dyspnea.
Outcome measures
| Measure |
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C37D1(n= 0, 5)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
24.44 Units on a scale
Standard Deviation 4.97
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: Baseline (n= 386, 407)
|
28.55 Units on a scale
Standard Deviation 23.21
|
26.78 Units on a scale
Standard Deviation 22.43
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C2D1(n= 335, 361)
|
28.14 Units on a scale
Standard Deviation 23.48
|
28.79 Units on a scale
Standard Deviation 23.67
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C3D1(n= 252, 301)
|
28.13 Units on a scale
Standard Deviation 22.45
|
25.40 Units on a scale
Standard Deviation 20.60
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C4D1(n= 220, 273)
|
27.75 Units on a scale
Standard Deviation 19.85
|
25.17 Units on a scale
Standard Deviation 21.14
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C5D1(n= 165, 236)
|
26.57 Units on a scale
Standard Deviation 19.61
|
24.72 Units on a scale
Standard Deviation 19.90
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C6D1(n= 148, 221)
|
29.69 Units on a scale
Standard Deviation 21.94
|
24.01 Units on a scale
Standard Deviation 21.09
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C7D1(n= 87, 187)
|
25.35 Units on a scale
Standard Deviation 21.07
|
24.42 Units on a scale
Standard Deviation 21.23
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C8D1(n=70, 167)
|
28.02 Units on a scale
Standard Deviation 24.12
|
24.42 Units on a scale
Standard Deviation 22.33
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C9D1(n= 50, 151)
|
26.00 Units on a scale
Standard Deviation 21.49
|
22.44 Units on a scale
Standard Deviation 21.87
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C10D1(n= 47, 143)
|
27.42 Units on a scale
Standard Deviation 22.56
|
22.18 Units on a scale
Standard Deviation 21.35
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C11D1(n= 37, 130)
|
22.67 Units on a scale
Standard Deviation 19.79
|
20.43 Units on a scale
Standard Deviation 21.44
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C12D1(n= 30, 129)
|
22.41 Units on a scale
Standard Deviation 18.94
|
22.27 Units on a scale
Standard Deviation 20.47
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C13D1(n= 19, 121)
|
16.37 Units on a scale
Standard Deviation 15.87
|
22.22 Units on a scale
Standard Deviation 21.52
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C14D1(n= 18, 119)
|
17.90 Units on a scale
Standard Deviation 12.13
|
22.41 Units on a scale
Standard Deviation 20.66
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C15D1(n= 16, 110)
|
15.28 Units on a scale
Standard Deviation 12.75
|
22.12 Units on a scale
Standard Deviation 18.71
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C16D1(n= 13, 106)
|
14.53 Units on a scale
Standard Deviation 13.13
|
21.91 Units on a scale
Standard Deviation 20.71
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C17D1(n= 10, 95)
|
18.89 Units on a scale
Standard Deviation 14.86
|
23.51 Units on a scale
Standard Deviation 21.84
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C18D1(n= 10, 90)
|
20.00 Units on a scale
Standard Deviation 12.61
|
22.65 Units on a scale
Standard Deviation 21.97
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C19D1(n= 9, 82)
|
18.52 Units on a scale
Standard Deviation 13.61
|
22.09 Units on a scale
Standard Deviation 20.91
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C20D1(n= 9, 78)
|
20.37 Units on a scale
Standard Deviation 15.21
|
22.65 Units on a scale
Standard Deviation 21.37
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C21D1(n= 9, 73)
|
19.75 Units on a scale
Standard Deviation 15.49
|
20.40 Units on a scale
Standard Deviation 19.69
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C22D1(n= 8, 67)
|
18.06 Units on a scale
Standard Deviation 20.52
|
19.90 Units on a scale
Standard Deviation 17.68
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C23D1(n= 8, 64)
|
16.67 Units on a scale
Standard Deviation 13.28
|
21.2 Units on a scale
Standard Deviation 19.13
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C24D1(n= 5, 62)
|
20.00 Units on a scale
Standard Deviation 14.49
|
21.33 Units on a scale
Standard Deviation 20.94
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C25D1(n= 3, 58)
|
29.63 Units on a scale
Standard Deviation 25.66
|
19.73 Units on a scale
Standard Deviation 18.39
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C26D1(n= 3, 53)
|
22.22 Units on a scale
Standard Deviation 11.11
|
21.80 Units on a scale
Standard Deviation 19.97
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C27D1(n= 3, 50)
|
18.52 Units on a scale
Standard Deviation 6.41
|
20.33 Units on a scale
Standard Deviation 20.87
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C28D1(n= 2, 46)
|
5.56 Units on a scale
Standard Deviation 7.86
|
18.36 Units on a scale
Standard Deviation 17.87
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C29D1(n= 2, 38)
|
5.56 Units on a scale
Standard Deviation 7.86
|
19.30 Units on a scale
Standard Deviation 16.48
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C30D1(n= 1, 31)
|
11.11 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
17.92 Units on a scale
Standard Deviation 17.14
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C31D1(n= 0, 24)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
24.07 Units on a scale
Standard Deviation 18.73
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C32D1(n= 0, 23)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
24.15 Units on a scale
Standard Deviation 20.00
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C33D1(n= 0,16)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
25.69 Units on a scale
Standard Deviation 27.13
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C34D1(n= 0, 14)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
27.78 Units on a scale
Standard Deviation 22.96
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C35D1(n= 0, 11)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
26.26 Units on a scale
Standard Deviation 19.42
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C36D1(n= 0, 8)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
18.06 Units on a scale
Standard Deviation 13.20
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: C38D1(n= 0, 2)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
16.67 Units on a scale
Standard Deviation 7.86
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: EOT(n= 263, 246)
|
36.12 Units on a scale
Standard Deviation 24.82
|
34.51 Units on a scale
Standard Deviation 26.36
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: Pro Week 6 Pd(n= 0,1)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
22.22 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Dyspnea: Survival FU 1 (n= 2, 1)
|
66.67 Units on a scale
Standard Deviation 15.71
|
44.44 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
SECONDARY outcome
Timeframe: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)Population: The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for hemoptysis.
Outcome measures
| Measure |
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: Baseline (n= 386, 406)
|
4.32 Units on a scale
Standard Deviation 13.32
|
3.86 Units on a scale
Standard Deviation 12.12
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C2D1(n= 336, 359)
|
4.76 Units on a scale
Standard Deviation 14.24
|
3.16 Units on a scale
Standard Deviation 10.97
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C3D1(n= 251, 301)
|
4.38 Units on a scale
Standard Deviation 13.11
|
3.10 Units on a scale
Standard Deviation 11.12
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C4D1(n= 220, 270)
|
2.88 Units on a scale
Standard Deviation 10.89
|
2.10 Units on a scale
Standard Deviation 9.94
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C5D1(n= 163, 234)
|
1.43 Units on a scale
Standard Deviation 7.72
|
1.42 Units on a scale
Standard Deviation 6.76
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C6D1(n= 148, 219)
|
1.80 Units on a scale
Standard Deviation 7.56
|
1.22 Units on a scale
Standard Deviation 6.27
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C7D1(n= 87, 187)
|
1.15 Units on a scale
Standard Deviation 6.12
|
1.43 Units on a scale
Standard Deviation 6.76
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C8D1(n=70, 166)
|
1.90 Units on a scale
Standard Deviation 9.64
|
2.41 Units on a scale
Standard Deviation 10.09
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C9D1(n= 50, 151)
|
2.00 Units on a scale
Standard Deviation 8.00
|
1.77 Units on a scale
Standard Deviation 7.49
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C10D1(n= 47, 143)
|
2.84 Units on a scale
Standard Deviation 9.40
|
0.70 Units on a scale
Standard Deviation 4.79
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C11D1(n= 37, 130)
|
1.80 Units on a scale
Standard Deviation 7.64
|
1.03 Units on a scale
Standard Deviation 5.78
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C12D1(n= 30, 129)
|
0.00 Units on a scale
Standard Deviation 0.00
|
1.03 Units on a scale
Standard Deviation 5.80
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C13D1(n= 19, 121)
|
3.51 Units on a scale
Standard Deviation 10.51
|
1.10 Units on a scale
Standard Deviation 5.98
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C14D1(n= 18, 119)
|
1.85 Units on a scale
Standard Deviation 7.86
|
1.68 Units on a scale
Standard Deviation 7.32
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C15D1(n= 16, 110)
|
0.00 Units on a scale
Standard Deviation 0.00
|
1.82 Units on a scale
Standard Deviation 10.91
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C16D1(n= 13, 106)
|
0.00 Units on a scale
Standard Deviation 0.00
|
2.83 Units on a scale
Standard Deviation 10.41
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C17D1(n= 11, 94)
|
0.00 Units on a scale
Standard Deviation 0.00
|
2.84 Units on a scale
Standard Deviation 12.61
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C18D1(n= 10, 90)
|
0.00 Units on a scale
Standard Deviation 0.00
|
2.96 Units on a scale
Standard Deviation 12.88
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C19D1(n= 9, 82)
|
0.00 Units on a scale
Standard Deviation 0.00
|
2.03 Units on a scale
Standard Deviation 12.11
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C20D1(n= 9, 78)
|
0.00 Units on a scale
Standard Deviation 0.00
|
2.56 Units on a scale
Standard Deviation 12.90
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C21D1(n= 8, 73)
|
0.00 Units on a scale
Standard Deviation 0.00
|
1.83 Units on a scale
Standard Deviation 7.64
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C22D1(n= 8, 67)
|
0.00 Units on a scale
Standard Deviation 0.00
|
1.99 Units on a scale
Standard Deviation 9.85
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C23D1(n= 8, 64)
|
0.00 Units on a scale
Standard Deviation 0.00
|
1.04 Units on a scale
Standard Deviation 5.85
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C24D1(n= 5, 61)
|
0.00 Units on a scale
Standard Deviation 0.00
|
2.73 Units on a scale
Standard Deviation 11.05
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C25D1(n= 3, 58)
|
0.00 Units on a scale
Standard Deviation 0.00
|
3.45 Units on a scale
Standard Deviation 13.52
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C26D1(n= 3, 53)
|
0.00 Units on a scale
Standard Deviation 0.00
|
3.77 Units on a scale
Standard Deviation 14.11
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C27D1(n= 3, 50)
|
0.00 Units on a scale
Standard Deviation 0.00
|
2.00 Units on a scale
Standard Deviation 8.00
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C28D1(n= 2, 46)
|
33.33 Units on a scale
Standard Deviation 47.14
|
1.45 Units on a scale
Standard Deviation 6.87
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C29D1(n= 2, 38)
|
0.00 Units on a scale
Standard Deviation 0.00
|
0.88 Units on a scale
Standard Deviation 5.41
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C30D1(n= 1, 31)
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
1.08 Units on a scale
Standard Deviation 5.99
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C31D1(n= 0, 24)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
2.78 Units on a scale
Standard Deviation 9.41
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C32D1(n= 0, 23)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
2.90 Units on a scale
Standard Deviation 9.60
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C33D1(n= 0,16)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
0.00 Units on a scale
Standard Deviation 0.00
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C34D1(n= 0, 14)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
0.00 Units on a scale
Standard Deviation 0.00
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C35D1(n= 0, 11)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
0.00 Units on a scale
Standard Deviation 0.00
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C36D1(n= 0, 8)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
4.17 Units on a scale
Standard Deviation 11.78
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C37D1(n= 0, 5)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
0.00 Units on a scale
Standard Deviation 0.00
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: C38D1(n= 0, 2)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
0.00 Units on a scale
Standard Deviation 0.00
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: EOT(n= 264, 243)
|
5.18 Units on a scale
Standard Deviation 14.33
|
6.04 Units on a scale
Standard Deviation 16.60
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: Pro Week 6 Pd(n= 0,1)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hemoptysis: Survival FU 1 (n= 2, 1)
|
33.33 Units on a scale
Standard Deviation 47.14
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
SECONDARY outcome
Timeframe: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)Population: The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in arm or shoulder.
Outcome measures
| Measure |
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: Baseline (n= 384, 405)
|
20.49 Units on a scale
Standard Deviation 28.85
|
20.16 Units on a scale
Standard Deviation 27.09
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C2D1(n= 332, 358)
|
19.58 Units on a scale
Standard Deviation 27.45
|
18.34 Units on a scale
Standard Deviation 26.56
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C3D1(n= 248, 294)
|
17.20 Units on a scale
Standard Deviation 27.16
|
16.44 Units on a scale
Standard Deviation 25.50
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C4D1(n= 217, 270)
|
14.75 Units on a scale
Standard Deviation 23.74
|
18.15 Units on a scale
Standard Deviation 26.57
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C5D1(n= 164, 232)
|
16.06 Units on a scale
Standard Deviation 24.06
|
14.94 Units on a scale
Standard Deviation 23.76
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C6D1(n= 147, 219)
|
15.42 Units on a scale
Standard Deviation 23.17
|
15.68 Units on a scale
Standard Deviation 24.37
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C7D1(n= 86, 184)
|
14.73 Units on a scale
Standard Deviation 23.77
|
16.67 Units on a scale
Standard Deviation 26.31
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C8D1(n=69, 163)
|
15.94 Units on a scale
Standard Deviation 25.95
|
16.77 Units on a scale
Standard Deviation 25.22
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C9D1(n= 50, 149)
|
14.00 Units on a scale
Standard Deviation 24.36
|
16.78 Units on a scale
Standard Deviation 25.89
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C10D1(n= 46, 141)
|
14.49 Units on a scale
Standard Deviation 20.67
|
17.73 Units on a scale
Standard Deviation 27.18
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C11D1(n= 36, 127)
|
11.11 Units on a scale
Standard Deviation 19.52
|
15.49 Units on a scale
Standard Deviation 26.82
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C12D1(n= 30, 126)
|
12.22 Units on a scale
Standard Deviation 18.54
|
16.93 Units on a scale
Standard Deviation 26.91
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C13D1(n= 19, 117)
|
12.28 Units on a scale
Standard Deviation 19.91
|
14.81 Units on a scale
Standard Deviation 22.93
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C14D1(n= 18, 117)
|
11.11 Units on a scale
Standard Deviation 19.80
|
15.67 Units on a scale
Standard Deviation 22.56
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C15D1(n= 16, 108)
|
12.50 Units on a scale
Standard Deviation 20.64
|
15.74 Units on a scale
Standard Deviation 24.31
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C16D1(n= 13, 104)
|
7.69 Units on a scale
Standard Deviation 14.62
|
14.10 Units on a scale
Standard Deviation 23.54
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C17D1(n= 11, 93)
|
9.09 Units on a scale
Standard Deviation 15.57
|
16.49 Units on a scale
Standard Deviation 25.83
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C18D1(n= 10, 88)
|
13.33 Units on a scale
Standard Deviation 23.31
|
18.18 Units on a scale
Standard Deviation 25.73
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C19D1(n= 9, 80)
|
7.41 Units on a scale
Standard Deviation 14.70
|
20.83 Units on a scale
Standard Deviation 29.23
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C20D1(n= 9, 76)
|
11.11 Units on a scale
Standard Deviation 23.57
|
18.42 Units on a scale
Standard Deviation 25.18
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C21D1(n= 9, 71)
|
11.11 Units on a scale
Standard Deviation 16.67
|
12.68 Units on a scale
Standard Deviation 19.81
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C22D1(n= 8, 65)
|
16.67 Units on a scale
Standard Deviation 25.20
|
13.33 Units on a scale
Standard Deviation 21.89
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C23D1(n= 8, 62)
|
16.67 Units on a scale
Standard Deviation 25.20
|
15.05 Units on a scale
Standard Deviation 22.32
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C24D1(n= 5, 59)
|
20.00 Units on a scale
Standard Deviation 29.81
|
18.08 Units on a scale
Standard Deviation 24.23
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C25D1(n= 3, 57)
|
11.11 Units on a scale
Standard Deviation 19.24
|
14.62 Units on a scale
Standard Deviation 21.84
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C26D1(n= 2, 52)
|
16.67 Units on a scale
Standard Deviation 23.57
|
15.38 Units on a scale
Standard Deviation 22.35
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C27D1(n= 3, 49)
|
11.11 Units on a scale
Standard Deviation 19.24
|
14.97 Units on a scale
Standard Deviation 23.63
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C28D1(n= 2, 45)
|
0.00 Units on a scale
Standard Deviation 0.00
|
11.85 Units on a scale
Standard Deviation 19.01
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C29D1(n= 2, 37)
|
0.00 Units on a scale
Standard Deviation 0.00
|
10.81 Units on a scale
Standard Deviation 22.30
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C30D1(n= 1, 30)
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
10.00 Units on a scale
Standard Deviation 21.71
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C31D1(n= 0, 23)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
10.14 Units on a scale
Standard Deviation 21.17
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C32D1(n= 0, 22)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
13.64 Units on a scale
Standard Deviation 26.55
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C33D1(n= 0, 15)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
20.00 Units on a scale
Standard Deviation 27.60
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C34D1(n= 0, 14)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
16.67 Units on a scale
Standard Deviation 28.49
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C35D1(n= 0, 11)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
27.27 Units on a scale
Standard Deviation 32.72
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C36D1(n= 0, 8)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
16.67 Units on a scale
Standard Deviation 35.63
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C37D1(n= 0, 5)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
33.33 Units on a scale
Standard Deviation 47.14
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: C38D1(n= 0, 2)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
0.00 Units on a scale
Standard Deviation 0.00
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: EOT(n= 264, 242)
|
21.72 Units on a scale
Standard Deviation 30.48
|
23.14 Units on a scale
Standard Deviation 29.55
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: Pro Week 6 Pd(n= 0,1)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
66.67 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Pain in Arm or Shoulder: Survival FU 1 (n= 2, 1)
|
83.33 Units on a scale
Standard Deviation 23.57
|
33.33 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
SECONDARY outcome
Timeframe: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)Population: The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in chest.
Outcome measures
| Measure |
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: Baseline (n= 385, 403)
|
17.92 Units on a scale
Standard Deviation 25.33
|
19.52 Units on a scale
Standard Deviation 26.49
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C2D1(n= 332, 356)
|
16.67 Units on a scale
Standard Deviation 24.65
|
15.26 Units on a scale
Standard Deviation 22.68
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C3D1(n= 249, 296)
|
14.59 Units on a scale
Standard Deviation 21.92
|
15.43 Units on a scale
Standard Deviation 23.42
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C4D1(n= 217, 268)
|
14.44 Units on a scale
Standard Deviation 22.37
|
14.43 Units on a scale
Standard Deviation 23.77
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C5D1(n= 164, 233)
|
11.99 Units on a scale
Standard Deviation 18.42
|
12.16 Units on a scale
Standard Deviation 19.82
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C6D1(n= 145, 217)
|
12.18 Units on a scale
Standard Deviation 19.96
|
12.60 Units on a scale
Standard Deviation 21.40
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C7D1(n= 86, 184)
|
12.40 Units on a scale
Standard Deviation 19.83
|
11.78 Units on a scale
Standard Deviation 20.91
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C8D1(n=69, 164)
|
10.63 Units on a scale
Standard Deviation 20.21
|
14.02 Units on a scale
Standard Deviation 21.52
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C9D1(n= 49, 149)
|
7.48 Units on a scale
Standard Deviation 17.03
|
10.74 Units on a scale
Standard Deviation 20.96
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C10D1(n= 46, 142)
|
5.07 Units on a scale
Standard Deviation 12.11
|
8.45 Units on a scale
Standard Deviation 19.62
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C11D1(n= 36, 127)
|
3.70 Units on a scale
Standard Deviation 10.62
|
9.45 Units on a scale
Standard Deviation 22.18
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C12D1(n= 30, 128)
|
3.33 Units on a scale
Standard Deviation 10.17
|
8.85 Units on a scale
Standard Deviation 17.49
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C13D1(n= 19, 120)
|
3.51 Units on a scale
Standard Deviation 10.51
|
7.50 Units on a scale
Standard Deviation 16.99
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C14D1(n= 18, 118)
|
5.56 Units on a scale
Standard Deviation 12.78
|
7.63 Units on a scale
Standard Deviation 15.96
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C15D1(n= 16, 109)
|
6.25 Units on a scale
Standard Deviation 13.44
|
8.56 Units on a scale
Standard Deviation 18.37
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C16D1(n= 13, 105)
|
5.13 Units on a scale
Standard Deviation 12.52
|
8.25 Units on a scale
Standard Deviation 16.53
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C17D1(n= 11, 94)
|
0.00 Units on a scale
Standard Deviation 0.00
|
8.87 Units on a scale
Standard Deviation 20.84
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C18D1(n= 10, 89)
|
6.67 Units on a scale
Standard Deviation 14.05
|
7.49 Units on a scale
Standard Deviation 15.69
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C19D1(n= 9, 80)
|
7.41 Units on a scale
Standard Deviation 14.70
|
7.50 Units on a scale
Standard Deviation 19.10
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C20D1(n= 9, 76)
|
3.70 Units on a scale
Standard Deviation 11.11
|
10.09 Units on a scale
Standard Deviation 20.38
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C21D1(n= 9, 71)
|
0.00 Units on a scale
Standard Deviation 0.00
|
7.98 Units on a scale
Standard Deviation 15.39
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C22D1(n= 8, 66)
|
4.17 Units on a scale
Standard Deviation 11.78
|
7.58 Units on a scale
Standard Deviation 16.33
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C23D1(n= 8, 62)
|
4.17 Units on a scale
Standard Deviation 11.78
|
7.53 Units on a scale
Standard Deviation 17.51
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C24D1(n= 5, 61)
|
0.00 Units on a scale
Standard Deviation 0.00
|
8.20 Units on a scale
Standard Deviation 15.70
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C25D1(n= 3, 57)
|
0.00 Units on a scale
Standard Deviation 0.00
|
8.77 Units on a scale
Standard Deviation 16.09
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C26D1(n= 2, 52)
|
0.00 Units on a scale
Standard Deviation 0.00
|
10.90 Units on a scale
Standard Deviation 19.49
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C27D1(n= 3, 49)
|
11.11 Units on a scale
Standard Deviation 19.24
|
8.84 Units on a scale
Standard Deviation 18.97
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C28D1(n= 2, 45)
|
0.00 Units on a scale
Standard Deviation 0.00
|
8.15 Units on a scale
Standard Deviation 16.14
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C29D1(n= 2, 37)
|
0.00 Units on a scale
Standard Deviation 0.00
|
8.11 Units on a scale
Standard Deviation 16.49
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C30D1(n= 1, 31)
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
5.38 Units on a scale
Standard Deviation 12.46
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C31D1(n= 0, 24)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
4.17 Units on a scale
Standard Deviation 11.26
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C32D1(n= 0, 23)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
13.04 Units on a scale
Standard Deviation 19.43
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C33D1(n= 0, 16)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
14.58 Units on a scale
Standard Deviation 24.25
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C34D1(n= 0, 14)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
14.29 Units on a scale
Standard Deviation 25.20
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C35D1(n= 0, 11)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
6.06 Units on a scale
Standard Deviation 13.48
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C36D1(n= 0, 8)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
4.17 Units on a scale
Standard Deviation 11.78
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C37D1(n= 0, 5)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
6.67 Units on a scale
Standard Deviation 14.91
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: C38D1(n= 0, 2)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
0.00 Units on a scale
Standard Deviation 0.00
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: EOT(n= 265, 245)
|
18.99 Units on a scale
Standard Deviation 26.35
|
19.46 Units on a scale
Standard Deviation 26.95
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: Pro Week 6 Pd(n= 0,1)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Pain in Chest: Survival FU 1 (n= 2, 1)
|
50.00 Units on a scale
Standard Deviation 70.71
|
33.33 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
SECONDARY outcome
Timeframe: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)Population: The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for peripheral neuropathy.
Outcome measures
| Measure |
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: Baseline (n= 386, 406)
|
19.26 Units on a scale
Standard Deviation 28.94
|
19.21 Units on a scale
Standard Deviation 27.77
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C2D1(n= 335, 358)
|
25.57 Units on a scale
Standard Deviation 29.63
|
20.02 Units on a scale
Standard Deviation 27.21
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C3D1(n= 250, 300)
|
25.60 Units on a scale
Standard Deviation 29.16
|
17.78 Units on a scale
Standard Deviation 25.04
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C4D1(n= 221, 272)
|
28.05 Units on a scale
Standard Deviation 29.94
|
17.77 Units on a scale
Standard Deviation 25.75
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C5D1(n= 165, 235)
|
29.29 Units on a scale
Standard Deviation 28.94
|
18.44 Units on a scale
Standard Deviation 25.97
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C6D1(n= 147, 221)
|
31.97 Units on a scale
Standard Deviation 30.69
|
17.50 Units on a scale
Standard Deviation 25.34
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C7D1(n= 86, 185)
|
31.01 Units on a scale
Standard Deviation 30.59
|
18.02 Units on a scale
Standard Deviation 25.29
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C8D1(n=70, 167)
|
35.24 Units on a scale
Standard Deviation 26.55
|
17.56 Units on a scale
Standard Deviation 25.30
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C9D1(n= 50, 150)
|
36.00 Units on a scale
Standard Deviation 29.23
|
15.78 Units on a scale
Standard Deviation 24.02
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C10D1(n= 47, 143)
|
36.17 Units on a scale
Standard Deviation 30.16
|
18.18 Units on a scale
Standard Deviation 25.86
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C11D1(n= 37, 129)
|
27.93 Units on a scale
Standard Deviation 24.23
|
17.05 Units on a scale
Standard Deviation 24.69
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C12D1(n= 30, 129)
|
30.00 Units on a scale
Standard Deviation 25.30
|
17.57 Units on a scale
Standard Deviation 23.96
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C13D1(n= 19, 121)
|
26.32 Units on a scale
Standard Deviation 21.02
|
17.91 Units on a scale
Standard Deviation 25.83
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C14D1(n= 18, 119)
|
25.93 Units on a scale
Standard Deviation 21.56
|
17.09 Units on a scale
Standard Deviation 23.72
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C15D1(n= 15, 110)
|
24.44 Units on a scale
Standard Deviation 15.26
|
17.58 Units on a scale
Standard Deviation 21.99
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C16D1(n= 13, 105)
|
20.51 Units on a scale
Standard Deviation 16.88
|
17.14 Units on a scale
Standard Deviation 24.07
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C17D1(n= 11, 95)
|
21.21 Units on a scale
Standard Deviation 16.82
|
19.30 Units on a scale
Standard Deviation 26.44
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C18D1(n= 10, 90)
|
23.33 Units on a scale
Standard Deviation 22.50
|
18.15 Units on a scale
Standard Deviation 26.52
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C19D1(n= 9, 82)
|
14.81 Units on a scale
Standard Deviation 17.57
|
20.33 Units on a scale
Standard Deviation 26.06
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C20D1(n= 9, 78)
|
22.22 Units on a scale
Standard Deviation 23.57
|
17.52 Units on a scale
Standard Deviation 26.17
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C21D1(n= 9, 73)
|
29.63 Units on a scale
Standard Deviation 20.03
|
18.72 Units on a scale
Standard Deviation 25.45
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C22D1(n= 7, 66)
|
23.81 Units on a scale
Standard Deviation 16.26
|
15.66 Units on a scale
Standard Deviation 23.55
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C23D1(n= 8, 64)
|
16.67 Units on a scale
Standard Deviation 17.82
|
20.31 Units on a scale
Standard Deviation 22.71
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C24D1(n= 5, 62)
|
13.33 Units on a scale
Standard Deviation 18.26
|
20.43 Units on a scale
Standard Deviation 22.87
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C25D1(n= 3, 58)
|
11.11 Units on a scale
Standard Deviation 19.24
|
18.39 Units on a scale
Standard Deviation 20.87
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C26D1(n= 2, 53)
|
16.67 Units on a scale
Standard Deviation 23.57
|
20.13 Units on a scale
Standard Deviation 25.60
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C27D1(n= 3, 50)
|
11.11 Units on a scale
Standard Deviation 19.24
|
19.33 Units on a scale
Standard Deviation 24.36
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C28D1(n= 2, 46)
|
0.00 Units on a scale
Standard Deviation 0.00
|
19.57 Units on a scale
Standard Deviation 22.85
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C29D1(n= 2, 38)
|
0.00 Units on a scale
Standard Deviation 0.00
|
19.30 Units on a scale
Standard Deviation 22.77
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C30D1(n= 1, 31)
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
20.43 Units on a scale
Standard Deviation 28.12
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C31D1(n= 0, 24)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
23.61 Units on a scale
Standard Deviation 26.88
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C32D1(n= 0, 23)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
18.84 Units on a scale
Standard Deviation 22.08
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C33D1(n= 0, 16)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
22.92 Units on a scale
Standard Deviation 20.07
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C34D1(n= 0, 14)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
19.05 Units on a scale
Standard Deviation 21.54
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C35D1(n= 0, 11)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
15.15 Units on a scale
Standard Deviation 17.41
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C36D1(n= 0, 8)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
8.33 Units on a scale
Standard Deviation 15.43
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C37D1(n= 0, 5)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
26.67 Units on a scale
Standard Deviation 27.89
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: C38D1(n= 0, 2)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
16.67 Units on a scale
Standard Deviation 23.57
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: EOT(n= 262, 244)
|
31.81 Units on a scale
Standard Deviation 31.53
|
19.54 Units on a scale
Standard Deviation 27.32
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: Pro Week 6 Pd(n= 0,1)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
66.67 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Peripheral Neuropathy: Survival FU 1 (n= 2, 1)
|
50.00 Units on a scale
Standard Deviation 23.57
|
33.33 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
SECONDARY outcome
Timeframe: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)Population: The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in other parts.
Outcome measures
| Measure |
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: Baseline (n= 373, 402)
|
27.52 Units on a scale
Standard Deviation 30.41
|
27.94 Units on a scale
Standard Deviation 31.52
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C2D1(n= 320, 347)
|
29.58 Units on a scale
Standard Deviation 30.44
|
27.76 Units on a scale
Standard Deviation 30.53
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C3D1(n= 239, 286)
|
22.87 Units on a scale
Standard Deviation 27.79
|
25.87 Units on a scale
Standard Deviation 29.79
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C4D1(n= 211, 263)
|
21.48 Units on a scale
Standard Deviation 26.86
|
23.45 Units on a scale
Standard Deviation 26.92
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C5D1(n= 154, 230)
|
21.21 Units on a scale
Standard Deviation 26.63
|
22.32 Units on a scale
Standard Deviation 27.24
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C6D1(n= 139, 214)
|
22.78 Units on a scale
Standard Deviation 25.39
|
21.50 Units on a scale
Standard Deviation 27.88
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C7D1(n= 81, 180)
|
23.05 Units on a scale
Standard Deviation 28.21
|
24.63 Units on a scale
Standard Deviation 29.56
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C8D1(n=65, 158)
|
24.10 Units on a scale
Standard Deviation 28.57
|
18.35 Units on a scale
Standard Deviation 24.54
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C9D1(n= 44, 135)
|
18.18 Units on a scale
Standard Deviation 28.26
|
21.48 Units on a scale
Standard Deviation 28.35
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C10D1(n= 44, 136)
|
15.15 Units on a scale
Standard Deviation 23.24
|
21.57 Units on a scale
Standard Deviation 28.84
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C11D1(n= 34, 123)
|
14.71 Units on a scale
Standard Deviation 23.49
|
20.05 Units on a scale
Standard Deviation 27.90
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C12D1(n= 26, 122)
|
8.97 Units on a scale
Standard Deviation 17.78
|
16.67 Units on a scale
Standard Deviation 25.80
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C13D1(n= 17, 113)
|
17.65 Units on a scale
Standard Deviation 23.91
|
19.76 Units on a scale
Standard Deviation 25.05
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C14D1(n= 18, 115)
|
18.52 Units on a scale
Standard Deviation 23.49
|
22.03 Units on a scale
Standard Deviation 29.58
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C15D1(n= 15, 106)
|
6.67 Units on a scale
Standard Deviation 13.80
|
19.18 Units on a scale
Standard Deviation 25.18
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C16D1(n= 13, 105)
|
20.51 Units on a scale
Standard Deviation 21.68
|
21.90 Units on a scale
Standard Deviation 26.89
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C17D1(n= 11, 93)
|
15.15 Units on a scale
Standard Deviation 22.92
|
22.22 Units on a scale
Standard Deviation 27.51
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C18D1(n= 10, 89)
|
13.33 Units on a scale
Standard Deviation 23.31
|
22.10 Units on a scale
Standard Deviation 27.50
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C19D1(n= 9, 80)
|
18.52 Units on a scale
Standard Deviation 24.22
|
24.58 Units on a scale
Standard Deviation 29.88
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C20D1(n= 9, 74)
|
25.93 Units on a scale
Standard Deviation 36.43
|
21.17 Units on a scale
Standard Deviation 27.90
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C21D1(n= 8, 69)
|
12.50 Units on a scale
Standard Deviation 17.25
|
21.26 Units on a scale
Standard Deviation 31.30
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C22D1(n= 8, 62)
|
20.83 Units on a scale
Standard Deviation 24.80
|
18.82 Units on a scale
Standard Deviation 25.34
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C23D1(n= 8, 62)
|
20.83 Units on a scale
Standard Deviation 30.54
|
18.82 Units on a scale
Standard Deviation 23.86
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C24D1(n= 5, 61)
|
26.67 Units on a scale
Standard Deviation 43.46
|
19.67 Units on a scale
Standard Deviation 28.14
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C25D1(n= 3, 55)
|
11.11 Units on a scale
Standard Deviation 19.24
|
16.97 Units on a scale
Standard Deviation 26.35
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C26D1(n= 2, 50)
|
16.67 Units on a scale
Standard Deviation 23.57
|
18.67 Units on a scale
Standard Deviation 26.22
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C27D1(n= 3, 49)
|
11.11 Units on a scale
Standard Deviation 19.24
|
14.29 Units on a scale
Standard Deviation 21.52
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C28D1(n= 2, 44)
|
0.00 Units on a scale
Standard Deviation 0.00
|
15.15 Units on a scale
Standard Deviation 25.37
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C29D1(n= 2, 36)
|
0.00 Units on a scale
Standard Deviation 0.00
|
21.30 Units on a scale
Standard Deviation 26.61
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C30D1(n= 1, 30)
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
16.67 Units on a scale
Standard Deviation 30.01
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C31D1(n= 0, 23)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
11.59 Units on a scale
Standard Deviation 21.58
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C32D1(n= 0, 23)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
20.29 Units on a scale
Standard Deviation 27.96
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C33D1(n= 0, 15)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
11.11 Units on a scale
Standard Deviation 27.22
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C34D1(n= 0, 14)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
30.95 Units on a scale
Standard Deviation 33.24
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C35D1(n= 0, 10)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
26.67 Units on a scale
Standard Deviation 34.43
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C36D1(n= 0, 8)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
20.83 Units on a scale
Standard Deviation 35.36
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C37D1(n= 0, 5)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
33.33 Units on a scale
Standard Deviation 40.82
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: C38D1(n= 0, 2)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
0.00 Units on a scale
Standard Deviation 0.00
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: EOT(n= 250, 226)
|
30.80 Units on a scale
Standard Deviation 32.97
|
32.01 Units on a scale
Standard Deviation 33.89
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: Pro Week 6 Pd(n= 0,1)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Pain in Other Parts: Survival FU 1 (n= 2, 1)
|
83.33 Units on a scale
Standard Deviation 23.57
|
66.67 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
SECONDARY outcome
Timeframe: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)Population: The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for sore mouth.
Outcome measures
| Measure |
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=425 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C12D1(n= 30, 129)
|
2.22 Units on a scale
Standard Deviation 8.46
|
4.65 Units on a scale
Standard Deviation 14.87
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: Baseline (n= 387, 404)
|
5.68 Units on a scale
Standard Deviation 16.34
|
4.95 Units on a scale
Standard Deviation 15.32
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C2D1(n= 335, 357)
|
15.52 Units on a scale
Standard Deviation 25.75
|
7.10 Units on a scale
Standard Deviation 18.17
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C3D1(n= 252, 297)
|
14.29 Units on a scale
Standard Deviation 23.59
|
5.61 Units on a scale
Standard Deviation 14.18
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C4D1(n= 219, 270)
|
14.00 Units on a scale
Standard Deviation 22.95
|
4.81 Units on a scale
Standard Deviation 13.99
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C5D1(n= 165, 234)
|
11.31 Units on a scale
Standard Deviation 19.65
|
4.27 Units on a scale
Standard Deviation 13.49
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C6D1(n= 148, 218)
|
13.29 Units on a scale
Standard Deviation 23.24
|
4.13 Units on a scale
Standard Deviation 13.89
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C7D1(n= 87, 185)
|
9.20 Units on a scale
Standard Deviation 20.77
|
5.59 Units on a scale
Standard Deviation 15.50
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C8D1(n=70, 166)
|
8.57 Units on a scale
Standard Deviation 16.73
|
5.02 Units on a scale
Standard Deviation 14.96
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C9D1(n= 50, 151)
|
6.00 Units on a scale
Standard Deviation 17.42
|
3.09 Units on a scale
Standard Deviation 14.06
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C10D1(n= 47, 143)
|
7.09 Units on a scale
Standard Deviation 15.44
|
3.96 Units on a scale
Standard Deviation 14.53
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C11D1(n= 37, 130)
|
4.50 Units on a scale
Standard Deviation 13.97
|
3.33 Units on a scale
Standard Deviation 12.35
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C13D1(n= 19, 121)
|
1.75 Units on a scale
Standard Deviation 7.65
|
5.23 Units on a scale
Standard Deviation 15.52
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C14D1(n= 18, 119)
|
3.70 Units on a scale
Standard Deviation 10.78
|
5.32 Units on a scale
Standard Deviation 15.64
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C15D1(n= 15, 110)
|
0.00 Units on a scale
Standard Deviation 0.00
|
4.24 Units on a scale
Standard Deviation 13.63
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C16D1(n= 13, 106)
|
0.00 Units on a scale
Standard Deviation 0.00
|
3.77 Units on a scale
Standard Deviation 16.15
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C17D1(n= 11, 95)
|
3.03 Units on a scale
Standard Deviation 10.05
|
6.32 Units on a scale
Standard Deviation 17.73
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C18D1(n= 10, 90)
|
3.33 Units on a scale
Standard Deviation 10.54
|
3.70 Units on a scale
Standard Deviation 11.66
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C19D1(n= 9, 82)
|
0.00 Units on a scale
Standard Deviation 0.00
|
4.47 Units on a scale
Standard Deviation 12.57
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C20D1(n= 9, 78)
|
0.00 Units on a scale
Standard Deviation 0.00
|
5.56 Units on a scale
Standard Deviation 15.59
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C21D1(n= 9, 73)
|
0.00 Units on a scale
Standard Deviation 0.00
|
7.76 Units on a scale
Standard Deviation 17.14
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C22D1(n= 8, 67)
|
4.17 Units on a scale
Standard Deviation 11.78
|
6.47 Units on a scale
Standard Deviation 17.64
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C23D1(n= 8, 64)
|
4.17 Units on a scale
Standard Deviation 11.78
|
6.25 Units on a scale
Standard Deviation 16.67
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C24D1(n= 5, 62)
|
0.00 Units on a scale
Standard Deviation 0.00
|
5.38 Units on a scale
Standard Deviation 13.75
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C25D1(n= 3, 57)
|
0.00 Units on a scale
Standard Deviation 0.00
|
3.51 Units on a scale
Standard Deviation 10.32
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C26D1(n= 3, 53)
|
0.00 Units on a scale
Standard Deviation 0.00
|
6.92 Units on a scale
Standard Deviation 13.65
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C27D1(n= 3, 50)
|
0.00 Units on a scale
Standard Deviation 0.00
|
4.00 Units on a scale
Standard Deviation 10.94
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C28D1(n= 2, 46)
|
0.00 Units on a scale
Standard Deviation 0.00
|
4.35 Units on a scale
Standard Deviation 11.35
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C29D1(n= 2, 38)
|
0.00 Units on a scale
Standard Deviation 0.00
|
3.51 Units on a scale
Standard Deviation 10.37
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C30D1(n= 1, 31)
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
4.30 Units on a scale
Standard Deviation 11.36
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C31D1(n= 0, 24)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
4.17 Units on a scale
Standard Deviation 11.26
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C32D1(n= 0, 23)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
4.35 Units on a scale
Standard Deviation 11.48
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C33D1(n= 0, 16)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
4.17 Units on a scale
Standard Deviation 11.39
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C34D1(n= 0, 14)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
9.52 Units on a scale
Standard Deviation 15.63
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C35D1(n= 0, 11)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
6.06 Units on a scale
Standard Deviation 13.48
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C36D1(n= 0, 8)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
4.17 Units on a scale
Standard Deviation 11.78
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C37D1(n= 0, 5)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
13.33 Units on a scale
Standard Deviation 29.81
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: C38D1(n= 0, 2)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
0.00 Units on a scale
Standard Deviation 0.00
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: EOT(n= 265, 243)
|
11.57 Units on a scale
Standard Deviation 22.85
|
7.00 Units on a scale
Standard Deviation 17.18
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: Pro Week 6 Pd(n= 0,1)
|
NA Units on a scale
Standard Deviation NA
Data not reported because no participant was evaluated for this category
|
66.67 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
|
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Sore Mouth: Survival FU 1 (n= 2, 1)
|
16.67 Units on a scale
Standard Deviation 23.57
|
0.00 Units on a scale
Standard Deviation NA
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
|
SECONDARY outcome
Timeframe: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)Population: SP-ITT analysis set.
PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.
Outcome measures
| Measure |
Atezolizumab
n=612 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=613 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
PFS as Determined by Investigator Using RECIST v1.1: SP-ITT
|
3.8 Months
Interval 3.3 to 4.1
|
2.7 Months
Interval 2.4 to 2.9
|
SECONDARY outcome
Timeframe: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)Population: SP-ITT analysis set.
Objective response is defined as a complete response (CR) or partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than \[\<\] 10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions.
Outcome measures
| Measure |
Atezolizumab
n=612 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=613 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants With Objective Response as Determined Using RECIST v1.1: SP-ITT
|
11.8 Percentage of Participants
Interval 9.32 to 14.59
|
13.7 Percentage of Participants
Interval 11.08 to 16.68
|
SECONDARY outcome
Timeframe: From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)Population: The SP-ITT analysis set.
DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.
Outcome measures
| Measure |
Atezolizumab
n=72 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=84 Participants
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
DOR as Determined by Investigator Using RECIST v1.1: SP ITT
|
6.3 Months
Interval 5.5 to 7.6
|
23.9 Months
Interval 12.8 to
Data not reported because the upper limit of confidence interval (CI) was not estimable due to higher number of censored participants.
|
Adverse Events
Docetaxel
Serious events: 180 serious events
Other events: 535 other events
Deaths: 0 deaths
Atezolizumab
Serious events: 200 serious events
Other events: 541 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Docetaxel
n=578 participants at risk
Docetaxel 75 milligrams per square meter (mg/m\^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=609 participants at risk
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
Nervous system disorders
Aphasia
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Nervous system disorders
Cerebral artery embolism
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Nervous system disorders
Cerebral thrombosis
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.33%
2/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Nervous system disorders
Dizziness
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.33%
2/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Nervous system disorders
Sciatica
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Nervous system disorders
Seizure
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.49%
3/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Nervous system disorders
Syncope
|
0.52%
3/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Psychiatric disorders
Confusional state
|
0.35%
2/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.69%
4/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Renal and urinary disorders
Henoch-Schonlein purpura nephritis
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.52%
3/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.33%
2/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
7/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
2.1%
13/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.87%
5/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.99%
6/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.49%
3/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.87%
5/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
1.8%
11/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural fistula
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.33%
2/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.99%
6/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.35%
2/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.49%
3/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.35%
2/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
1.5%
9/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.35%
2/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.35%
2/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.49%
3/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Vascular disorders
Deep vein thrombosis
|
0.35%
2/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Vascular disorders
Haematoma
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Vascular disorders
Hypotension
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.49%
3/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.49%
3/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Localised infection
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Psychiatric disorders
Mental status change
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
7/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.82%
5/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.4%
37/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.52%
3/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.35%
2/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Cardiac disorders
Angina pectoris
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Cardiac disorders
Arrhythmia
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Cardiac disorders
Atrial fibrillation
|
0.52%
3/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Cardiac disorders
Atrial flutter
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Cardiac disorders
Cardiac arrest
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.33%
2/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.33%
2/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Cardiac disorders
Pericardial effusion
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.49%
3/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.35%
2/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Cardiac disorders
Tachycardia
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Eye disorders
Retinopathy
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.69%
4/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.33%
2/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Colitis
|
0.35%
2/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.33%
2/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
7/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Dysphagia
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Haematochezia
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Nausea
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.33%
2/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Oesophageal fistula
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Stomatitis
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Subileus
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Vomiting
|
0.87%
5/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
General disorders
Asthenia
|
0.52%
3/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.49%
3/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
General disorders
Chest discomfort
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
General disorders
Chest pain
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
General disorders
Death
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
General disorders
Fatigue
|
0.69%
4/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.33%
2/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
General disorders
General physical health deterioration
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.33%
2/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
General disorders
Generalised oedema
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
General disorders
Influenza like illness
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
General disorders
Localised oedema
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
General disorders
Oedema peripheral
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.33%
2/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
General disorders
Pain
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
General disorders
Pyrexia
|
1.4%
8/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
1.5%
9/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
General disorders
Sudden death
|
0.35%
2/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.33%
2/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.49%
3/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Abdominal sepsis
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Appendicitis
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Bacterial sepsis
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Bronchitis
|
0.35%
2/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Cellulitis
|
0.35%
2/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Device related infection
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Diverticulitis
|
0.35%
2/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Gastroenteritis
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Gastrointestinal fungal infection
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Gastrointestinal infection
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Infection
|
0.35%
2/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Influenza
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.33%
2/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.52%
3/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.49%
3/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Lung infection
|
0.52%
3/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.49%
3/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Meningitis
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.49%
3/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Neutropenic sepsis
|
0.35%
2/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Paronychia
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Parotitis
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.33%
2/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Pleural infection
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Pneumonia
|
5.9%
34/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
3.3%
20/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.33%
2/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Respiratory tract infection
|
0.69%
4/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
1.3%
8/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Sepsis
|
0.35%
2/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.82%
5/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Septic shock
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Skin infection
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Urinary tract infection
|
0.35%
2/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Investigations
White blood cell count decreased
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Injury, poisoning and procedural complications
Fall
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.49%
3/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Investigations
Neutrophil count decreased
|
0.87%
5/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.52%
3/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.49%
3/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.33%
2/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.35%
2/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.49%
3/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.66%
4/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.33%
2/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.17%
1/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.00%
0/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
Other adverse events
| Measure |
Docetaxel
n=578 participants at risk
Docetaxel 75 milligrams per square meter (mg/m\^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
Atezolizumab
n=609 participants at risk
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|---|---|---|
|
Investigations
Weight decreased
|
5.2%
30/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
9.2%
56/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Urinary tract infection
|
5.2%
30/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
3.6%
22/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Investigations
Alanine aminotransferase increased
|
2.4%
14/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
5.9%
36/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Investigations
Aspartate aminotransferase increased
|
2.1%
12/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
6.9%
42/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Investigations
Neutrophil count decreased
|
8.7%
50/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.49%
3/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Blood and lymphatic system disorders
Anaemia
|
22.5%
130/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
11.7%
71/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Blood and lymphatic system disorders
Neutropenia
|
15.2%
88/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
2.0%
12/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Eye disorders
Lacrimation increased
|
5.7%
33/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.99%
6/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.7%
33/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
3.8%
23/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Constipation
|
14.2%
82/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
18.2%
111/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.9%
138/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
16.4%
100/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Nausea
|
22.7%
131/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
18.1%
110/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Stomatitis
|
10.7%
62/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
3.4%
21/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Gastrointestinal disorders
Vomiting
|
10.6%
61/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
12.3%
75/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
General disorders
Asthenia
|
19.6%
113/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
19.2%
117/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
General disorders
Chest pain
|
4.3%
25/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
9.0%
55/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
General disorders
Fatigue
|
35.6%
206/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
27.1%
165/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
General disorders
Influenza like illness
|
2.4%
14/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
5.7%
35/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
General disorders
Malaise
|
5.0%
29/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
2.5%
15/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
General disorders
Mucosal inflammation
|
7.1%
41/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
1.5%
9/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
General disorders
Oedema peripheral
|
14.2%
82/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
9.0%
55/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
General disorders
Pyrexia
|
12.1%
70/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
17.7%
108/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Nasopharyngitis
|
3.6%
21/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
6.4%
39/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.6%
15/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
6.7%
41/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.4%
135/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
24.6%
150/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.2%
59/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
13.1%
80/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
41/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
11.5%
70/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.2%
24/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
11.3%
69/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.6%
90/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
7.2%
44/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.6%
38/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
9.2%
56/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Nervous system disorders
Dizziness
|
5.5%
32/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
7.9%
48/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Nervous system disorders
Dysgeusia
|
8.3%
48/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
3.0%
18/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Nervous system disorders
Headache
|
8.0%
46/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
10.2%
62/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Nervous system disorders
Neuropathy peripheral
|
11.2%
65/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
4.4%
27/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Nervous system disorders
Paraesthesia
|
7.8%
45/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
3.8%
23/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.4%
43/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.82%
5/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Psychiatric disorders
Depression
|
1.0%
6/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
5.1%
31/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Psychiatric disorders
Insomnia
|
7.4%
43/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
9.2%
56/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.5%
107/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
24.0%
146/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.7%
108/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
19.2%
117/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
4.8%
28/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
6.6%
40/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
35.5%
205/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.82%
5/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.9%
34/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
4.9%
30/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
5.2%
30/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
0.16%
1/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.1%
18/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
9.4%
57/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.8%
51/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
10.7%
65/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Infections and infestations
Bronchitis
|
4.2%
24/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
5.6%
34/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.2%
7/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
5.4%
33/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.6%
21/578 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
5.9%
36/609 • Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
|
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