Trial Outcomes & Findings for A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110] (NCT NCT02409342)
NCT ID: NCT02409342
Last Updated: 2023-03-15
Results Overview
OS is defined as the time from randomization to death from any cause.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
572 participants
Primary outcome timeframe
From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months)
Results posted on
2023-03-15
Participant Flow
Recruitment included: Japan (16 centers), Spain (15 centers), Greece (12 centers), Italy (12 centers), Brazil (11 centers), Russian (11 centers), France (10 centers), United States of America (9 centers), Ukraine (8 centers), Romania (7 centers), Turkey (6 centers), Poland (5 centers), Serbia (5 centers), Hungary (4 centers), Thailand (4 centers), Great Britain (3 centers), Republic of Korea (3 centers), Germany (2 centers), China (1 center).
Study is considered 'Completed' because all of the criteria for End of Study have been met. Participants in survival follow-up completed their last visit and participants on active treatment were rolled over to a rollover study to continue their treatment.
Participant milestones
| Measure |
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
|
Atezolizumab
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
|
|---|---|---|
|
Overall Study
STARTED
|
287
|
285
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
287
|
285
|
Reasons for withdrawal
| Measure |
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
|
Atezolizumab
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
|
|---|---|---|
|
Overall Study
Death
|
211
|
201
|
|
Overall Study
Withdrawal by Subject
|
24
|
17
|
|
Overall Study
Study Terminated By Sponsor
|
48
|
59
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
|
Overall Study
Local ethics requires subjects' data be removed from aug 2020 to currently.
|
0
|
1
|
|
Overall Study
Participant Moved Into Roll-Over Study
|
0
|
2
|
|
Overall Study
Sponsor Decision
|
1
|
0
|
Baseline Characteristics
A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110]
Baseline characteristics by cohort
| Measure |
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
n=287 Participants
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
|
Atezolizumab
n=285 Participants
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
|
Total
n=572 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.8 Years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
63.1 Years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
63.4 Years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
198 Participants
n=5 Participants
|
198 Participants
n=7 Participants
|
396 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
265 Participants
n=5 Participants
|
262 Participants
n=7 Participants
|
527 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
33 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
247 Participants
n=5 Participants
|
232 Participants
n=7 Participants
|
479 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months)Population: Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]).
OS is defined as the time from randomization to death from any cause.
Outcome measures
| Measure |
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
n=98 Participants
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
|
Atezolizumab
n=107 Participants
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
|
|---|---|---|
|
Overall Survival (OS) in the TC3 or IC3-WT Populations
|
13.1 Months
Interval 7.4 to 16.5
|
20.2 Months
Interval 16.5 to
Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
|
PRIMARY outcome
Timeframe: From randomization to death from any cause until data cut-off on 4 February 2020 (up to approximately 54.5 months)Population: Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]).
OS is defined as the time from randomization to death from any cause.
Outcome measures
| Measure |
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
n=277 Participants
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
|
Atezolizumab
n=277 Participants
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
|
|---|---|---|
|
Overall Survival (OS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
TC2/3 or IC2/3-WT Population
|
16.1 Months
Interval 12.6 to 18.0
|
19.9 Months
Interval 17.2 to 25.3
|
|
Overall Survival (OS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
TC1/2/3 or IC1/2/3-WT Population
|
14.7 Months
Interval 11.2 to 16.5
|
18.9 Months
Interval 13.4 to 23.0
|
SECONDARY outcome
Timeframe: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)Population: Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]).
PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first. PFS could not be formally tested.
Outcome measures
| Measure |
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
n=98 Participants
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
|
Atezolizumab
n=107 Participants
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
|
|---|---|---|
|
Progression-free Survival (PFS) in the TC3 or IC3-WT Populations
|
5.0 Months
Interval 4.2 to 5.7
|
8.1 Months
Interval 6.8 to 11.0
|
SECONDARY outcome
Timeframe: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 4 February 2020 (up to approximately 54.5 months)Population: Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]).
PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first. PFS could not be formally tested.
Outcome measures
| Measure |
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
n=277 Participants
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
|
Atezolizumab
n=277 Participants
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
|
|---|---|---|
|
Progression-free Survival (PFS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
TC2/3 or IC2/3-WT Population
|
5.5 Months
Interval 4.5 to 5.7
|
7.3 Months
Interval 5.6 to 9.3
|
|
Progression-free Survival (PFS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
TC1/2/3 or IC1/2/3-WT Population
|
5.6 Months
Interval 4.7 to 5.7
|
5.8 Months
Interval 5.5 to 7.3
|
SECONDARY outcome
Timeframe: Every 6 weeks for 48 weeks following Day 1, thereafter every 9 weeks after completion of Week 48 tumor assessment, regardless of treatment delays, until radiographic disease progression until data cut-off on 10 Sep 2018 (up to approximately 38 months)Population: Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]).
Objective response (partial response plus complete response) as determined by the investigator according to RECIST v1.1.
Outcome measures
| Measure |
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
n=98 Participants
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
|
Atezolizumab
n=107 Participants
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
|
|---|---|---|
|
Percentage of Participants With Objective Response (ORR) in the TC3 or IC3-WT Populations
|
28.6 Percentage of participants
|
38.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Every 6 weeks for 48 weeks following Day 1, thereafter every 9 weeks after completion of Week 48 tumor assessment, regardless of treatment delays, until radiographic disease progression until data cut-off on 4 Feb 2020 (up to approximately 54.5 months)Population: Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]).
Objective response (partial response plus complete response) as determined by the investigator according to RECIST v1.1.
Outcome measures
| Measure |
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
n=277 Participants
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
|
Atezolizumab
n=277 Participants
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
|
|---|---|---|
|
Percentage of Participants With Objective Response (ORR) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
TC2/3 or IC2/3-WT Population
|
32.1 Percentage of participants
|
33.7 Percentage of participants
|
|
Percentage of Participants With Objective Response (ORR) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
TC1/2/3 or IC1/2/3-WT Population
|
32.1 Percentage of participants
|
31.4 Percentage of participants
|
SECONDARY outcome
Timeframe: From first occurrence of a complete response or partial response, whichever occurs first, until first date that progressive disease or death is documented, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)Population: Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]).
DOR is defined as the time from the first occurrence of a documented objective response to the time of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first.
Outcome measures
| Measure |
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
n=28 Participants
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
|
Atezolizumab
n=41 Participants
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
|
|---|---|---|
|
Duration of Response (DOR) in the TC3 or IC3-WT Populations
|
6.7 Months
Interval 5.5 to 17.3
|
NA Months
Interval 11.8 to
Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
|
SECONDARY outcome
Timeframe: From first occurrence of a complete response or partial response, whichever occurs first, until first date that progressive disease or death is documented, whichever occurs first until data cut-off on 4 February 2020 (up to approximately 54.5 months)Population: Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]).
DOR is defined as the time from the first occurrence of a documented objective response to the time of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first.
Outcome measures
| Measure |
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
n=89 Participants
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
|
Atezolizumab
n=87 Participants
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
|
|---|---|---|
|
Duration of Response (DOR) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
TC2/3 or IC2/3-WT Population
|
5.8 Months
Interval 5.1 to 9.8
|
38.9 Months
Interval 16.9 to
Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
|
|
Duration of Response (DOR) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
TC1/2/3 or IC1/2/3-WT Population
|
5.7 Months
Interval 5.1 to 8.8
|
26.3 Months
Interval 16.1 to 43.7
|
SECONDARY outcome
Timeframe: Baseline to 1 year or death, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)Population: Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]).
Outcome measures
| Measure |
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
n=98 Participants
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
|
Atezolizumab
n=107 Participants
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
|
|---|---|---|
|
Percentage of Participants Who Are Alive at 1 Year in the TC3 or IC3-WT Populations
|
50.64 Percentage of participants
Interval 40.0 to 61.27
|
64.90 Percentage of participants
Interval 55.36 to 74.43
|
SECONDARY outcome
Timeframe: Baseline to 2 years or death, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)Population: Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]).
Outcome measures
| Measure |
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
n=98 Participants
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
|
Atezolizumab
n=107 Participants
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
|
|---|---|---|
|
Percentage of Participants Who Are Alive at 2 Years in the TC3 or IC3-WT Populations
|
24.79 Percentage of participants
Interval 13.11 to 36.47
|
45.49 Percentage of participants
Interval 32.11 to 58.88
|
SECONDARY outcome
Timeframe: Baseline to 1 year or death, whichever occurs first until clinical cut-off date on 4 February 2020 (up to approximately 54.5 months)Population: Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]).
Outcome measures
| Measure |
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
n=277 Participants
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
|
Atezolizumab
n=277 Participants
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
|
|---|---|---|
|
Percentage of Participants Who Are Alive at 1 Year in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
1-Year TC2/3 or IC2/3-WT Population
|
58.65 Percentage of participants
Interval 50.95 to 66.35
|
63.39 Percentage of participants
Interval 56.0 to 70.77
|
|
Percentage of Participants Who Are Alive at 1 Year in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
1-Year TC1/2/3 or IC1/2/3-WT Population
|
54.89 Percentage of participants
Interval 48.93 to 60.84
|
59.95 Percentage of participants
Interval 54.12 to 65.78
|
SECONDARY outcome
Timeframe: Baseline to 2 years or death, whichever occurs first until clinical cut-off date on 4 February 2020 (up to approximately 54.5 months)Population: Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]).
Outcome measures
| Measure |
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
n=277 Participants
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
|
Atezolizumab
n=277 Participants
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
|
|---|---|---|
|
Percentage of Participants Who Are Alive at 2 Years in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
2-Years TC2/3 or IC2/3-WT Population
|
35.42 Percentage of participants
Interval 27.91 to 42.94
|
44.15 Percentage of participants
Interval 36.51 to 51.8
|
|
Percentage of Participants Who Are Alive at 2 Years in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
2-Years TC1/2/3 or IC1/2/3-WT Population
|
30.82 Percentage of participants
Interval 25.28 to 36.36
|
41.76 Percentage of participants
Interval 35.84 to 47.67
|
SECONDARY outcome
Timeframe: Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)Population: Analysis was performed for the TC3 or IC3-WT Populations.
TTD in each of the patient-reported lung cancer symptoms with use of the SILC scale. The SILC scale is a nine-item content valid self-report measure of lung cancer symptoms. It measures severity of cough, dyspnea, and chest pain with a total symptom severity score. Each SILC symptom scale (dyspnea, cough, chest pain) score was calculated as the average of the component items (range 0 to 4). An increase in score suggested worsening in symptomatology. A symptom score change of 0.3 points for the dyspnea and cough scores was considered to be clinically significant; whereas a symptom score change of 0.5 points for the chest pain score was considered to be clinically significant.
Outcome measures
| Measure |
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
n=98 Participants
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
|
Atezolizumab
n=107 Participants
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
|
|---|---|---|
|
Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Score as Assessed by the Symptoms in Lung Cancer (SILC) Scale Symptom Score in the TC3 or IC3-WT Populations
Cough
|
3.4 Months
Interval 1.3 to 12.4
|
3.5 Months
Interval 1.0 to 10.8
|
|
Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Score as Assessed by the Symptoms in Lung Cancer (SILC) Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnea
|
1.0 Months
Interval 0.5 to 1.9
|
1.3 Months
Interval 0.7 to 3.6
|
|
Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Score as Assessed by the Symptoms in Lung Cancer (SILC) Scale Symptom Score in the TC3 or IC3-WT Populations
Chest pain
|
1.1 Months
Interval 0.7 to
Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
|
1.7 Months
Interval 0.7 to 4.5
|
SECONDARY outcome
Timeframe: Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)Population: Analysis was performed for the TC3 or IC3-WT Populations.
Change from baseline in each of the patient-reported lung cancer symptoms with use of the SILC scale. The SILC scale is a nine-item content valid self-report measure of lung cancer symptoms. It measures severity of cough, dyspnea, and chest pain with a total symptom severity score. Each SILC symptom scale (dyspnea, cough, chest pain) score was calculated as the average of the component items (range 0 to 4). An increase in score suggested worsening in symptomatology. A symptom score change of 0.3 points for the dyspnea and cough scores was considered to be clinically significant; whereas a symptom score change of 0.5 points for the chest pain score was considered to be clinically significant.
Outcome measures
| Measure |
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
n=52 Participants
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
|
Atezolizumab
n=61 Participants
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
|
|---|---|---|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 114
|
—
|
0.50 Score on a scale
Standard Deviation 2.12
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 115
|
—
|
0.50 Score on a scale
Standard Deviation 2.12
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 116
|
—
|
0.50 Score on a scale
Standard Deviation 2.12
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 117
|
—
|
0.50 Score on a scale
Standard Deviation 2.12
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 118
|
—
|
0.50 Score on a scale
Standard Deviation 2.12
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 119
|
—
|
0.50 Score on a scale
Standard Deviation 2.12
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 120
|
—
|
2.00 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 121
|
—
|
2.00 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 122
|
—
|
2.00 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 123
|
—
|
2.00 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 124
|
—
|
2.00 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 125
|
—
|
2.00 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 126
|
—
|
2.00 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 127
|
—
|
2.00 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 128
|
—
|
2.00 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 129
|
—
|
2.00 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 130
|
—
|
2.00 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 131
|
—
|
2.00 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 1
|
0.42 Score on a scale
Standard Deviation 0.81
|
0.12 Score on a scale
Standard Deviation 0.76
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 2
|
0.33 Score on a scale
Standard Deviation 0.73
|
0.29 Score on a scale
Standard Deviation 0.87
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 3
|
0.25 Score on a scale
Standard Deviation 0.75
|
0.25 Score on a scale
Standard Deviation 0.97
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 4
|
0.43 Score on a scale
Standard Deviation 0.87
|
0.28 Score on a scale
Standard Deviation 0.89
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 61
|
0.50 Score on a scale
Standard Deviation 0.50
|
0.00 Score on a scale
Standard Deviation 0.88
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 62
|
0.33 Score on a scale
Standard Deviation 0.58
|
0.14 Score on a scale
Standard Deviation 0.79
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 63
|
0.00 Score on a scale
Standard Deviation 0.00
|
-0.04 Score on a scale
Standard Deviation 0.86
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 64
|
0.00 Score on a scale
|
0.35 Score on a scale
Standard Deviation 1.00
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 65
|
0.50 Score on a scale
|
0.12 Score on a scale
Standard Deviation 0.92
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 66
|
0.00 Score on a scale
|
0.45 Score on a scale
Standard Deviation 1.21
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 67
|
0.25 Score on a scale
Standard Deviation 0.35
|
-0.09 Score on a scale
Standard Deviation 0.66
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 68
|
0.25 Score on a scale
Standard Deviation 0.35
|
0.61 Score on a scale
Standard Deviation 1.29
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 69
|
0.25 Score on a scale
Standard Deviation 0.35
|
0.50 Score on a scale
Standard Deviation 1.18
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 70
|
0.25 Score on a scale
Standard Deviation 0.35
|
0.23 Score on a scale
Standard Deviation 0.79
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 1
|
0.57 Score on a scale
Standard Deviation 1.23
|
0.31 Score on a scale
Standard Deviation 0.84
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 2
|
0.42 Score on a scale
Standard Deviation 1.13
|
0.33 Score on a scale
Standard Deviation 0.85
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 3
|
0.25 Score on a scale
Standard Deviation 1.26
|
0.43 Score on a scale
Standard Deviation 0.97
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 4
|
0.15 Score on a scale
Standard Deviation 1.21
|
0.43 Score on a scale
Standard Deviation 1.08
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 5
|
0.27 Score on a scale
Standard Deviation 1.19
|
0.28 Score on a scale
Standard Deviation 1.00
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 6
|
0.30 Score on a scale
Standard Deviation 1.26
|
0.25 Score on a scale
Standard Deviation 0.85
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 7
|
0.23 Score on a scale
Standard Deviation 1.04
|
0.30 Score on a scale
Standard Deviation 0.97
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 8
|
0.17 Score on a scale
Standard Deviation 1.12
|
0.20 Score on a scale
Standard Deviation 0.82
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 9
|
0.27 Score on a scale
Standard Deviation 1.00
|
0.33 Score on a scale
Standard Deviation 1.07
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 10
|
0.30 Score on a scale
Standard Deviation 1.13
|
0.25 Score on a scale
Standard Deviation 1.12
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 11
|
0.26 Score on a scale
Standard Deviation 1.32
|
0.21 Score on a scale
Standard Deviation 0.96
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 12
|
0.22 Score on a scale
Standard Deviation 1.33
|
0.33 Score on a scale
Standard Deviation 0.97
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 13
|
0.07 Score on a scale
Standard Deviation 1.17
|
0.30 Score on a scale
Standard Deviation 1.04
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 14
|
0.07 Score on a scale
Standard Deviation 1.16
|
0.27 Score on a scale
Standard Deviation 0.85
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 15
|
0.10 Score on a scale
Standard Deviation 1.23
|
0.45 Score on a scale
Standard Deviation 1.01
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 16
|
0.00 Score on a scale
Standard Deviation 1.20
|
0.19 Score on a scale
Standard Deviation 0.99
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 17
|
0.22 Score on a scale
Standard Deviation 1.41
|
0.22 Score on a scale
Standard Deviation 1.20
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 18
|
0.11 Score on a scale
Standard Deviation 1.26
|
0.26 Score on a scale
Standard Deviation 0.85
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 19
|
0.11 Score on a scale
Standard Deviation 1.01
|
0.23 Score on a scale
Standard Deviation 0.94
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 20
|
0.20 Score on a scale
Standard Deviation 1.32
|
0.23 Score on a scale
Standard Deviation 0.95
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 21
|
0.03 Score on a scale
Standard Deviation 0.83
|
0.11 Score on a scale
Standard Deviation 0.87
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 22
|
0.30 Score on a scale
Standard Deviation 1.35
|
0.19 Score on a scale
Standard Deviation 1.02
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 23
|
0.00 Score on a scale
Standard Deviation 1.00
|
0.33 Score on a scale
Standard Deviation 0.84
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 24
|
-0.09 Score on a scale
Standard Deviation 0.88
|
0.18 Score on a scale
Standard Deviation 1.13
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 25
|
0.27 Score on a scale
Standard Deviation 0.79
|
0.29 Score on a scale
Standard Deviation 0.87
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 26
|
0.12 Score on a scale
Standard Deviation 1.31
|
0.11 Score on a scale
Standard Deviation 0.72
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 27
|
0.05 Score on a scale
Standard Deviation 1.15
|
0.20 Score on a scale
Standard Deviation 0.80
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 28
|
0.00 Score on a scale
Standard Deviation 0.81
|
0.23 Score on a scale
Standard Deviation 0.98
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 29
|
-0.25 Score on a scale
Standard Deviation 0.87
|
0.18 Score on a scale
Standard Deviation 0.80
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 30
|
0.21 Score on a scale
Standard Deviation 1.45
|
0.32 Score on a scale
Standard Deviation 0.95
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 31
|
0.18 Score on a scale
Standard Deviation 1.72
|
0.33 Score on a scale
Standard Deviation 0.90
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 32
|
0.41 Score on a scale
Standard Deviation 1.61
|
0.35 Score on a scale
Standard Deviation 1.20
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 33
|
0.00 Score on a scale
Standard Deviation 1.44
|
0.04 Score on a scale
Standard Deviation 1.03
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 34
|
0.40 Score on a scale
Standard Deviation 1.31
|
0.31 Score on a scale
Standard Deviation 0.98
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 35
|
0.00 Score on a scale
Standard Deviation 1.16
|
0.28 Score on a scale
Standard Deviation 1.13
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 36
|
0.06 Score on a scale
Standard Deviation 0.85
|
0.08 Score on a scale
Standard Deviation 0.95
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 37
|
0.31 Score on a scale
Standard Deviation 1.25
|
0.39 Score on a scale
Standard Deviation 0.89
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 38
|
0.23 Score on a scale
Standard Deviation 0.72
|
0.31 Score on a scale
Standard Deviation 1.20
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 39
|
0.22 Score on a scale
Standard Deviation 1.00
|
0.14 Score on a scale
Standard Deviation 0.92
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 40
|
0.43 Score on a scale
Standard Deviation 1.02
|
0.30 Score on a scale
Standard Deviation 1.21
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 41
|
0.36 Score on a scale
Standard Deviation 1.07
|
0.30 Score on a scale
Standard Deviation 1.01
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 42
|
0.25 Score on a scale
Standard Deviation 1.04
|
0.33 Score on a scale
Standard Deviation 1.05
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 43
|
0.30 Score on a scale
Standard Deviation 1.15
|
0.18 Score on a scale
Standard Deviation 1.29
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 44
|
0.14 Score on a scale
Standard Deviation 0.99
|
0.42 Score on a scale
Standard Deviation 1.15
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 45
|
0.63 Score on a scale
Standard Deviation 0.48
|
0.31 Score on a scale
Standard Deviation 0.90
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 46
|
0.30 Score on a scale
Standard Deviation 0.45
|
0.37 Score on a scale
Standard Deviation 0.93
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 47
|
0.50 Score on a scale
Standard Deviation 0.71
|
0.31 Score on a scale
Standard Deviation 0.86
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 48
|
0.50 Score on a scale
Standard Deviation 0.50
|
0.17 Score on a scale
Standard Deviation 0.79
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 49
|
1.00 Score on a scale
Standard Deviation 1.32
|
0.47 Score on a scale
Standard Deviation 1.07
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 50
|
0.80 Score on a scale
Standard Deviation 0.91
|
0.20 Score on a scale
Standard Deviation 0.92
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 51
|
0.88 Score on a scale
Standard Deviation 0.85
|
0.31 Score on a scale
Standard Deviation 0.89
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 52
|
0.75 Score on a scale
Standard Deviation 1.19
|
0.54 Score on a scale
Standard Deviation 1.11
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 53
|
0.70 Score on a scale
Standard Deviation 0.84
|
0.29 Score on a scale
Standard Deviation 1.08
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 54
|
1.13 Score on a scale
Standard Deviation 1.03
|
0.25 Score on a scale
Standard Deviation 0.87
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 55
|
1.17 Score on a scale
Standard Deviation 1.26
|
0.15 Score on a scale
Standard Deviation 0.99
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 56
|
0.38 Score on a scale
Standard Deviation 0.48
|
0.29 Score on a scale
Standard Deviation 0.96
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 57
|
0.67 Score on a scale
Standard Deviation 0.58
|
0.08 Score on a scale
Standard Deviation 0.73
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 58
|
1.17 Score on a scale
Standard Deviation 1.04
|
0.19 Score on a scale
Standard Deviation 1.07
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 59
|
1.00 Score on a scale
Standard Deviation 0.87
|
0.00 Score on a scale
Standard Deviation 0.87
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 60
|
0.50 Score on a scale
Standard Deviation 1.41
|
0.38 Score on a scale
Standard Deviation 1.08
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 61
|
1.00 Score on a scale
Standard Deviation 0.87
|
0.36 Score on a scale
Standard Deviation 1.12
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 62
|
0.83 Score on a scale
Standard Deviation 0.76
|
0.43 Score on a scale
Standard Deviation 1.16
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 63
|
0.50 Score on a scale
Standard Deviation 0.71
|
0.29 Score on a scale
Standard Deviation 0.86
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 64
|
0.00 Score on a scale
|
0.40 Score on a scale
Standard Deviation 1.22
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 65
|
0.00 Score on a scale
|
0.35 Score on a scale
Standard Deviation 1.11
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 66
|
0.00 Score on a scale
|
0.45 Score on a scale
Standard Deviation 1.44
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 67
|
1.00 Score on a scale
Standard Deviation 1.41
|
-0.09 Score on a scale
Standard Deviation 0.80
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 68
|
0.75 Score on a scale
Standard Deviation 1.06
|
0.39 Score on a scale
Standard Deviation 1.45
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 69
|
0.50 Score on a scale
Standard Deviation 0.71
|
0.50 Score on a scale
Standard Deviation 1.33
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 70
|
1.00 Score on a scale
Standard Deviation 1.41
|
0.18 Score on a scale
Standard Deviation 0.81
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 71
|
0.50 Score on a scale
Standard Deviation 0.71
|
0.45 Score on a scale
Standard Deviation 1.32
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 72
|
1.00 Score on a scale
|
0.42 Score on a scale
Standard Deviation 1.18
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 73
|
1.50 Score on a scale
|
0.27 Score on a scale
Standard Deviation 1.19
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 74
|
0.50 Score on a scale
Standard Deviation 0.71
|
0.50 Score on a scale
Standard Deviation 1.30
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 75
|
0.75 Score on a scale
Standard Deviation 1.06
|
0.33 Score on a scale
Standard Deviation 1.32
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 76
|
0.50 Score on a scale
Standard Deviation 0.71
|
0.00 Score on a scale
Standard Deviation 0.93
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 77
|
0.50 Score on a scale
Standard Deviation 0.71
|
0.19 Score on a scale
Standard Deviation 1.33
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 78
|
1.00 Score on a scale
Standard Deviation 1.41
|
0.21 Score on a scale
Standard Deviation 1.44
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 79
|
0.50 Score on a scale
Standard Deviation 0.71
|
0.31 Score on a scale
Standard Deviation 1.31
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 80
|
0.75 Score on a scale
Standard Deviation 1.06
|
0.72 Score on a scale
Standard Deviation 1.70
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 81
|
0.75 Score on a scale
Standard Deviation 1.06
|
0.08 Score on a scale
Standard Deviation 1.72
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 82
|
0.00 Score on a scale
|
0.08 Score on a scale
Standard Deviation 1.24
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 83
|
0.00 Score on a scale
|
0.50 Score on a scale
Standard Deviation 1.48
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 84
|
0.50 Score on a scale
|
0.43 Score on a scale
Standard Deviation 1.43
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 85
|
0.00 Score on a scale
|
0.38 Score on a scale
Standard Deviation 1.41
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 86
|
0.00 Score on a scale
|
0.21 Score on a scale
Standard Deviation 1.44
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 87
|
0.00 Score on a scale
|
0.29 Score on a scale
Standard Deviation 1.41
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 88
|
—
|
0.43 Score on a scale
Standard Deviation 1.17
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 89
|
—
|
-0.20 Score on a scale
Standard Deviation 0.91
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 90
|
—
|
0.07 Score on a scale
Standard Deviation 1.13
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 91
|
—
|
-0.07 Score on a scale
Standard Deviation 0.89
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 92
|
—
|
0.33 Score on a scale
Standard Deviation 1.54
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 93
|
—
|
0.50 Score on a scale
Standard Deviation 1.47
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 94
|
—
|
0.20 Score on a scale
Standard Deviation 1.35
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 95
|
—
|
0.33 Score on a scale
Standard Deviation 1.54
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 96
|
—
|
0.33 Score on a scale
Standard Deviation 1.54
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 97
|
—
|
0.50 Score on a scale
Standard Deviation 1.47
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 98
|
—
|
0.33 Score on a scale
Standard Deviation 1.54
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 99
|
—
|
0.88 Score on a scale
Standard Deviation 1.18
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 100
|
—
|
0.50 Score on a scale
Standard Deviation 1.00
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 101
|
—
|
0.83 Score on a scale
Standard Deviation 0.93
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 102
|
—
|
0.50 Score on a scale
Standard Deviation 1.00
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 103
|
—
|
0.63 Score on a scale
Standard Deviation 1.11
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 104
|
—
|
1.00 Score on a scale
Standard Deviation 1.00
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 105
|
—
|
1.00 Score on a scale
Standard Deviation 1.00
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 106
|
—
|
0.50 Score on a scale
Standard Deviation 0.71
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 107
|
—
|
1.00 Score on a scale
Standard Deviation 1.00
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 108
|
—
|
1.50 Score on a scale
Standard Deviation 0.71
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 109
|
—
|
1.75 Score on a scale
Standard Deviation 1.06
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 110
|
—
|
2.00 Score on a scale
Standard Deviation 1.41
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 111
|
—
|
1.50 Score on a scale
Standard Deviation 0.71
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 112
|
—
|
1.50 Score on a scale
Standard Deviation 0.71
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 113
|
—
|
1.50 Score on a scale
Standard Deviation 0.71
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 114
|
—
|
2.00 Score on a scale
Standard Deviation 1.41
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 115
|
—
|
1.75 Score on a scale
Standard Deviation 1.06
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 116
|
—
|
2.00 Score on a scale
Standard Deviation 1.41
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 117
|
—
|
2.00 Score on a scale
Standard Deviation 1.41
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 118
|
—
|
2.00 Score on a scale
Standard Deviation 1.41
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 119
|
—
|
1.75 Score on a scale
Standard Deviation 1.06
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 120
|
—
|
2.50 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 121
|
—
|
2.00 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 122
|
—
|
3.00 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 123
|
—
|
2.50 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 124
|
—
|
3.00 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 125
|
—
|
3.00 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 126
|
—
|
3.00 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 127
|
—
|
2.00 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 128
|
—
|
3.00 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 129
|
—
|
3.00 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 130
|
—
|
2.00 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Chest Pain, Week 131
|
—
|
2.00 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 1
|
0.13 Score on a scale
Standard Deviation 0.86
|
0.10 Score on a scale
Standard Deviation 0.70
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 2
|
-0.01 Score on a scale
Standard Deviation 0.99
|
0.19 Score on a scale
Standard Deviation 0.75
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 3
|
-0.03 Score on a scale
Standard Deviation 0.76
|
-0.01 Score on a scale
Standard Deviation 0.76
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 4
|
-0.02 Score on a scale
Standard Deviation 1.02
|
-0.03 Score on a scale
Standard Deviation 0.98
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 5
|
-0.01 Score on a scale
Standard Deviation 0.84
|
0.00 Score on a scale
Standard Deviation 0.96
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 6
|
-0.18 Score on a scale
Standard Deviation 0.93
|
-0.18 Score on a scale
Standard Deviation 0.89
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 7
|
-0.20 Score on a scale
Standard Deviation 0.92
|
-0.06 Score on a scale
Standard Deviation 0.98
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 8
|
-0.10 Score on a scale
Standard Deviation 0.90
|
-0.13 Score on a scale
Standard Deviation 0.91
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 9
|
-0.24 Score on a scale
Standard Deviation 0.86
|
-0.06 Score on a scale
Standard Deviation 1.01
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 10
|
-0.07 Score on a scale
Standard Deviation 1.12
|
-0.10 Score on a scale
Standard Deviation 1.02
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 11
|
0.02 Score on a scale
Standard Deviation 1.24
|
-0.07 Score on a scale
Standard Deviation 1.07
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 12
|
-0.08 Score on a scale
Standard Deviation 1.30
|
-0.09 Score on a scale
Standard Deviation 0.97
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 13
|
-0.09 Score on a scale
Standard Deviation 1.22
|
-0.20 Score on a scale
Standard Deviation 0.93
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 14
|
-0.20 Score on a scale
Standard Deviation 1.19
|
-0.07 Score on a scale
Standard Deviation 0.95
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 15
|
-0.05 Score on a scale
Standard Deviation 1.35
|
-0.19 Score on a scale
Standard Deviation 1.04
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 16
|
-0.10 Score on a scale
Standard Deviation 1.06
|
-0.19 Score on a scale
Standard Deviation 0.94
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 17
|
-0.04 Score on a scale
Standard Deviation 0.99
|
-0.21 Score on a scale
Standard Deviation 1.09
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 18
|
0.02 Score on a scale
Standard Deviation 1.23
|
-0.26 Score on a scale
Standard Deviation 0.93
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 19
|
-0.23 Score on a scale
Standard Deviation 1.29
|
-0.27 Score on a scale
Standard Deviation 0.87
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 20
|
0.00 Score on a scale
Standard Deviation 1.33
|
-0.33 Score on a scale
Standard Deviation 0.95
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 21
|
-0.17 Score on a scale
Standard Deviation 1.40
|
-0.19 Score on a scale
Standard Deviation 0.88
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 22
|
-0.20 Score on a scale
Standard Deviation 1.32
|
-0.17 Score on a scale
Standard Deviation 0.89
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 23
|
-0.22 Score on a scale
Standard Deviation 1.18
|
0.05 Score on a scale
Standard Deviation 0.90
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 24
|
-0.13 Score on a scale
Standard Deviation 1.51
|
-0.12 Score on a scale
Standard Deviation 0.80
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 25
|
-0.45 Score on a scale
Standard Deviation 0.96
|
0.14 Score on a scale
Standard Deviation 0.82
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 26
|
-0.46 Score on a scale
Standard Deviation 1.20
|
-0.03 Score on a scale
Standard Deviation 0.89
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 27
|
-0.50 Score on a scale
Standard Deviation 1.22
|
-0.05 Score on a scale
Standard Deviation 0.94
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 28
|
-0.45 Score on a scale
Standard Deviation 0.88
|
0.08 Score on a scale
Standard Deviation 0.84
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 29
|
-0.50 Score on a scale
Standard Deviation 1.31
|
0.05 Score on a scale
Standard Deviation 0.67
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 30
|
-0.88 Score on a scale
Standard Deviation 1.13
|
0.12 Score on a scale
Standard Deviation 0.88
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 31
|
-0.86 Score on a scale
Standard Deviation 1.40
|
0.05 Score on a scale
Standard Deviation 0.74
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 32
|
-0.73 Score on a scale
Standard Deviation 1.56
|
-0.04 Score on a scale
Standard Deviation 1.04
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 33
|
-0.77 Score on a scale
Standard Deviation 1.13
|
-0.29 Score on a scale
Standard Deviation 1.06
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 34
|
-0.80 Score on a scale
Standard Deviation 1.18
|
-0.02 Score on a scale
Standard Deviation 0.75
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 35
|
-0.14 Score on a scale
Standard Deviation 0.95
|
-0.09 Score on a scale
Standard Deviation 1.10
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 36
|
-0.17 Score on a scale
Standard Deviation 0.66
|
-0.36 Score on a scale
Standard Deviation 1.16
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 37
|
-0.25 Score on a scale
Standard Deviation 0.89
|
-0.04 Score on a scale
Standard Deviation 0.84
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 38
|
0.05 Score on a scale
Standard Deviation 0.88
|
-0.07 Score on a scale
Standard Deviation 1.11
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 39
|
-0.50 Score on a scale
Standard Deviation 0.90
|
-0.20 Score on a scale
Standard Deviation 0.97
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 40
|
-0.36 Score on a scale
Standard Deviation 0.94
|
-0.39 Score on a scale
Standard Deviation 1.23
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 41
|
0.21 Score on a scale
Standard Deviation 0.57
|
0.05 Score on a scale
Standard Deviation 0.84
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 42
|
0.17 Score on a scale
Standard Deviation 0.52
|
-0.20 Score on a scale
Standard Deviation 1.16
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 43
|
0.10 Score on a scale
Standard Deviation 0.55
|
0.03 Score on a scale
Standard Deviation 1.06
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 44
|
0.36 Score on a scale
Standard Deviation 0.94
|
-0.11 Score on a scale
Standard Deviation 1.09
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 45
|
0.25 Score on a scale
Standard Deviation 0.50
|
-0.26 Score on a scale
Standard Deviation 0.92
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 46
|
0.10 Score on a scale
Standard Deviation 0.96
|
0.08 Score on a scale
Standard Deviation 0.85
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 47
|
0.50 Score on a scale
Standard Deviation 0.58
|
-0.03 Score on a scale
Standard Deviation 0.90
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 48
|
0.17 Score on a scale
Standard Deviation 0.29
|
0.23 Score on a scale
Standard Deviation 0.68
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 49
|
0.67 Score on a scale
Standard Deviation 0.76
|
0.26 Score on a scale
Standard Deviation 0.85
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 50
|
0.30 Score on a scale
Standard Deviation 0.76
|
0.00 Score on a scale
Standard Deviation 0.85
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 51
|
0.13 Score on a scale
Standard Deviation 0.63
|
0.06 Score on a scale
Standard Deviation 0.93
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 52
|
0.63 Score on a scale
Standard Deviation 0.95
|
0.27 Score on a scale
Standard Deviation 0.97
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 71
|
0.00 Score on a scale
Standard Deviation 0.00
|
0.55 Score on a scale
Standard Deviation 0.90
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 72
|
-0.50 Score on a scale
|
0.42 Score on a scale
Standard Deviation 0.93
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 73
|
0.00 Score on a scale
|
0.64 Score on a scale
Standard Deviation 1.07
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 74
|
0.00 Score on a scale
Standard Deviation 0.00
|
0.56 Score on a scale
Standard Deviation 1.04
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 75
|
0.00 Score on a scale
Standard Deviation 0.71
|
0.67 Score on a scale
Standard Deviation 1.35
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 76
|
0.25 Score on a scale
Standard Deviation 0.35
|
0.31 Score on a scale
Standard Deviation 1.00
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 77
|
0.00 Score on a scale
Standard Deviation 0.00
|
0.56 Score on a scale
Standard Deviation 1.15
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 78
|
0.25 Score on a scale
Standard Deviation 0.35
|
0.36 Score on a scale
Standard Deviation 1.03
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 79
|
0.00 Score on a scale
Standard Deviation 0.00
|
0.63 Score on a scale
Standard Deviation 1.19
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 80
|
0.25 Score on a scale
Standard Deviation 0.35
|
0.33 Score on a scale
Standard Deviation 0.90
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 81
|
0.25 Score on a scale
Standard Deviation 0.35
|
0.58 Score on a scale
Standard Deviation 1.28
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 84
|
0.50 Score on a scale
|
0.29 Score on a scale
Standard Deviation 0.95
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 82
|
0.00 Score on a scale
|
0.25 Score on a scale
Standard Deviation 1.08
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 83
|
0.00 Score on a scale
|
0.67 Score on a scale
Standard Deviation 1.21
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 85
|
0.00 Score on a scale
|
0.38 Score on a scale
Standard Deviation 1.03
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 86
|
0.00 Score on a scale
|
0.57 Score on a scale
Standard Deviation 1.24
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 87
|
0.00 Score on a scale
|
0.64 Score on a scale
Standard Deviation 1.35
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 88
|
—
|
0.64 Score on a scale
Standard Deviation 1.14
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 89
|
—
|
0.50 Score on a scale
Standard Deviation 1.32
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 90
|
—
|
0.43 Score on a scale
Standard Deviation 1.10
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 91
|
—
|
0.50 Score on a scale
Standard Deviation 1.19
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 92
|
—
|
0.67 Score on a scale
Standard Deviation 1.21
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 100
|
—
|
0.60 Score on a scale
Standard Deviation 1.14
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 93
|
—
|
0.79 Score on a scale
Standard Deviation 1.38
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 94
|
—
|
0.30 Score on a scale
Standard Deviation 0.97
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 95
|
—
|
0.67 Score on a scale
Standard Deviation 1.25
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 96
|
—
|
0.58 Score on a scale
Standard Deviation 1.20
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 97
|
—
|
0.57 Score on a scale
Standard Deviation 1.13
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 98
|
—
|
0.67 Score on a scale
Standard Deviation 1.25
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 99
|
—
|
0.25 Score on a scale
Standard Deviation 0.96
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 101
|
—
|
0.50 Score on a scale
Standard Deviation 1.05
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 102
|
—
|
0.50 Score on a scale
Standard Deviation 1.00
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 103
|
—
|
0.25 Score on a scale
Standard Deviation 0.96
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 104
|
—
|
0.00 Score on a scale
Standard Deviation 1.00
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 105
|
—
|
0.33 Score on a scale
Standard Deviation 1.53
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 106
|
—
|
-0.50 Score on a scale
Standard Deviation 0.71
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 107
|
—
|
0.00 Score on a scale
Standard Deviation 1.00
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 108
|
—
|
0.00 Score on a scale
Standard Deviation 1.41
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 109
|
—
|
0.50 Score on a scale
Standard Deviation 2.12
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 110
|
—
|
0.50 Score on a scale
Standard Deviation 2.12
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 111
|
—
|
0.50 Score on a scale
Standard Deviation 2.12
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 112
|
—
|
0.00 Score on a scale
Standard Deviation 1.41
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 113
|
—
|
0.50 Score on a scale
Standard Deviation 2.12
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 5
|
0.55 Score on a scale
Standard Deviation 0.81
|
0.21 Score on a scale
Standard Deviation 1.00
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 6
|
0.50 Score on a scale
Standard Deviation 0.68
|
0.21 Score on a scale
Standard Deviation 0.95
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 7
|
0.63 Score on a scale
Standard Deviation 0.74
|
0.32 Score on a scale
Standard Deviation 1.08
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 8
|
0.50 Score on a scale
Standard Deviation 0.64
|
0.25 Score on a scale
Standard Deviation 1.00
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 9
|
0.46 Score on a scale
Standard Deviation 0.86
|
0.34 Score on a scale
Standard Deviation 1.01
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 10
|
0.43 Score on a scale
Standard Deviation 0.80
|
0.49 Score on a scale
Standard Deviation 1.12
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 11
|
0.36 Score on a scale
Standard Deviation 0.77
|
0.24 Score on a scale
Standard Deviation 0.97
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 12
|
0.39 Score on a scale
Standard Deviation 0.82
|
0.35 Score on a scale
Standard Deviation 1.04
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 13
|
0.43 Score on a scale
Standard Deviation 0.83
|
0.23 Score on a scale
Standard Deviation 0.94
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 14
|
0.26 Score on a scale
Standard Deviation 0.88
|
0.26 Score on a scale
Standard Deviation 1.14
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 15
|
0.36 Score on a scale
Standard Deviation 1.07
|
0.39 Score on a scale
Standard Deviation 1.22
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 16
|
0.18 Score on a scale
Standard Deviation 0.82
|
0.26 Score on a scale
Standard Deviation 1.13
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 17
|
0.48 Score on a scale
Standard Deviation 0.87
|
0.16 Score on a scale
Standard Deviation 1.17
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 18
|
0.39 Score on a scale
Standard Deviation 0.65
|
0.21 Score on a scale
Standard Deviation 1.05
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 19
|
0.29 Score on a scale
Standard Deviation 0.86
|
0.33 Score on a scale
Standard Deviation 1.12
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 20
|
0.60 Score on a scale
Standard Deviation 0.87
|
0.23 Score on a scale
Standard Deviation 1.00
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 21
|
0.27 Score on a scale
Standard Deviation 0.69
|
0.40 Score on a scale
Standard Deviation 0.93
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 22
|
0.55 Score on a scale
Standard Deviation 0.92
|
0.22 Score on a scale
Standard Deviation 0.99
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 23
|
0.34 Score on a scale
Standard Deviation 0.69
|
0.38 Score on a scale
Standard Deviation 0.98
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 24
|
0.36 Score on a scale
Standard Deviation 1.02
|
0.42 Score on a scale
Standard Deviation 1.06
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 25
|
0.22 Score on a scale
Standard Deviation 0.46
|
0.50 Score on a scale
Standard Deviation 1.14
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 26
|
0.32 Score on a scale
Standard Deviation 0.82
|
0.28 Score on a scale
Standard Deviation 0.95
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 27
|
0.35 Score on a scale
Standard Deviation 1.07
|
0.37 Score on a scale
Standard Deviation 1.04
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 28
|
0.35 Score on a scale
Standard Deviation 0.92
|
0.45 Score on a scale
Standard Deviation 0.83
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 29
|
0.20 Score on a scale
Standard Deviation 0.89
|
0.38 Score on a scale
Standard Deviation 0.85
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 30
|
0.18 Score on a scale
Standard Deviation 0.96
|
0.54 Score on a scale
Standard Deviation 1.01
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 31
|
0.18 Score on a scale
Standard Deviation 0.84
|
0.41 Score on a scale
Standard Deviation 0.86
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 32
|
0.22 Score on a scale
Standard Deviation 1.00
|
0.58 Score on a scale
Standard Deviation 1.04
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 33
|
0.20 Score on a scale
Standard Deviation 0.78
|
0.36 Score on a scale
Standard Deviation 0.96
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 34
|
0.16 Score on a scale
Standard Deviation 0.79
|
0.28 Score on a scale
Standard Deviation 1.00
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 35
|
0.11 Score on a scale
Standard Deviation 0.58
|
0.27 Score on a scale
Standard Deviation 1.02
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 36
|
0.11 Score on a scale
Standard Deviation 0.86
|
-0.02 Score on a scale
Standard Deviation 1.04
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 37
|
0.28 Score on a scale
Standard Deviation 0.63
|
0.42 Score on a scale
Standard Deviation 1.13
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 38
|
0.40 Score on a scale
Standard Deviation 0.76
|
0.50 Score on a scale
Standard Deviation 1.25
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 39
|
0.27 Score on a scale
Standard Deviation 0.81
|
0.25 Score on a scale
Standard Deviation 0.86
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 40
|
0.57 Score on a scale
Standard Deviation 0.76
|
0.44 Score on a scale
Standard Deviation 1.13
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 41
|
0.31 Score on a scale
Standard Deviation 0.58
|
0.53 Score on a scale
Standard Deviation 1.17
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 42
|
0.30 Score on a scale
Standard Deviation 0.55
|
0.52 Score on a scale
Standard Deviation 1.07
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 43
|
0.40 Score on a scale
Standard Deviation 0.57
|
0.41 Score on a scale
Standard Deviation 1.18
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 44
|
0.49 Score on a scale
Standard Deviation 0.60
|
0.31 Score on a scale
Standard Deviation 1.14
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 45
|
0.65 Score on a scale
Standard Deviation 0.38
|
0.53 Score on a scale
Standard Deviation 1.04
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 46
|
0.56 Score on a scale
Standard Deviation 0.71
|
0.37 Score on a scale
Standard Deviation 0.97
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 47
|
0.30 Score on a scale
Standard Deviation 0.68
|
0.39 Score on a scale
Standard Deviation 0.92
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 48
|
0.60 Score on a scale
Standard Deviation 0.72
|
0.39 Score on a scale
Standard Deviation 0.93
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 49
|
1.40 Score on a scale
Standard Deviation 1.20
|
0.47 Score on a scale
Standard Deviation 0.76
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 50
|
0.24 Score on a scale
Standard Deviation 0.59
|
0.53 Score on a scale
Standard Deviation 0.96
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 51
|
1.05 Score on a scale
Standard Deviation 1.02
|
0.59 Score on a scale
Standard Deviation 1.02
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 52
|
1.10 Score on a scale
Standard Deviation 1.01
|
0.72 Score on a scale
Standard Deviation 1.20
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 53
|
0.76 Score on a scale
Standard Deviation 1.28
|
0.40 Score on a scale
Standard Deviation 1.01
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 54
|
1.10 Score on a scale
Standard Deviation 1.16
|
0.63 Score on a scale
Standard Deviation 1.02
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 55
|
1.00 Score on a scale
Standard Deviation 0.53
|
0.72 Score on a scale
Standard Deviation 1.13
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 56
|
0.40 Score on a scale
Standard Deviation 0.86
|
0.61 Score on a scale
Standard Deviation 1.07
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 57
|
0.53 Score on a scale
Standard Deviation 0.61
|
0.45 Score on a scale
Standard Deviation 1.02
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 58
|
0.80 Score on a scale
Standard Deviation 0.53
|
0.60 Score on a scale
Standard Deviation 1.20
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 59
|
0.60 Score on a scale
Standard Deviation 0.72
|
0.18 Score on a scale
Standard Deviation 1.08
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 60
|
1.20 Score on a scale
Standard Deviation 1.13
|
0.57 Score on a scale
Standard Deviation 0.89
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 61
|
0.73 Score on a scale
Standard Deviation 0.76
|
0.54 Score on a scale
Standard Deviation 1.00
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 62
|
0.67 Score on a scale
Standard Deviation 0.83
|
0.66 Score on a scale
Standard Deviation 1.11
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 63
|
0.30 Score on a scale
Standard Deviation 0.42
|
0.77 Score on a scale
Standard Deviation 0.80
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 64
|
0.20 Score on a scale
|
0.66 Score on a scale
Standard Deviation 1.07
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 65
|
0.60 Score on a scale
|
0.94 Score on a scale
Standard Deviation 1.28
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 66
|
0.40 Score on a scale
|
0.67 Score on a scale
Standard Deviation 1.31
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 67
|
0.50 Score on a scale
Standard Deviation 0.14
|
0.33 Score on a scale
Standard Deviation 0.87
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 68
|
0.20 Score on a scale
Standard Deviation 0.28
|
0.82 Score on a scale
Standard Deviation 1.56
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 69
|
0.30 Score on a scale
Standard Deviation 0.42
|
0.74 Score on a scale
Standard Deviation 1.11
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 70
|
0.30 Score on a scale
Standard Deviation 0.42
|
0.75 Score on a scale
Standard Deviation 1.16
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 71
|
0.10 Score on a scale
Standard Deviation 0.14
|
0.84 Score on a scale
Standard Deviation 1.19
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 72
|
0.00 Score on a scale
|
0.80 Score on a scale
Standard Deviation 1.09
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 73
|
0.00 Score on a scale
|
0.67 Score on a scale
Standard Deviation 1.11
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 74
|
0.20 Score on a scale
Standard Deviation 0.28
|
0.89 Score on a scale
Standard Deviation 1.35
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 75
|
0.30 Score on a scale
Standard Deviation 0.42
|
0.71 Score on a scale
Standard Deviation 1.31
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 76
|
0.30 Score on a scale
Standard Deviation 0.42
|
0.53 Score on a scale
Standard Deviation 1.05
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 77
|
0.40 Score on a scale
Standard Deviation 0.57
|
0.65 Score on a scale
Standard Deviation 1.55
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 78
|
0.30 Score on a scale
Standard Deviation 0.14
|
0.40 Score on a scale
Standard Deviation 1.11
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 79
|
0.10 Score on a scale
Standard Deviation 0.14
|
0.55 Score on a scale
Standard Deviation 1.25
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 80
|
0.50 Score on a scale
Standard Deviation 0.71
|
0.69 Score on a scale
Standard Deviation 1.43
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 81
|
0.40 Score on a scale
Standard Deviation 0.57
|
0.53 Score on a scale
Standard Deviation 1.53
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 82
|
0.60 Score on a scale
|
0.53 Score on a scale
Standard Deviation 1.09
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 83
|
0.60 Score on a scale
|
0.87 Score on a scale
Standard Deviation 1.28
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 84
|
0.80 Score on a scale
|
0.89 Score on a scale
Standard Deviation 1.13
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 85
|
0.60 Score on a scale
|
0.83 Score on a scale
Standard Deviation 1.27
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 86
|
0.40 Score on a scale
|
0.66 Score on a scale
Standard Deviation 1.33
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 87
|
0.40 Score on a scale
|
0.66 Score on a scale
Standard Deviation 1.23
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 88
|
—
|
1.20 Score on a scale
Standard Deviation 1.43
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 89
|
—
|
0.56 Score on a scale
Standard Deviation 1.05
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 90
|
—
|
0.74 Score on a scale
Standard Deviation 1.38
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 91
|
—
|
0.51 Score on a scale
Standard Deviation 1.00
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 92
|
—
|
0.87 Score on a scale
Standard Deviation 1.26
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 93
|
—
|
1.20 Score on a scale
Standard Deviation 1.39
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 94
|
—
|
0.48 Score on a scale
Standard Deviation 0.99
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 95
|
—
|
0.87 Score on a scale
Standard Deviation 1.32
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 96
|
—
|
1.13 Score on a scale
Standard Deviation 1.24
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 97
|
—
|
1.26 Score on a scale
Standard Deviation 1.35
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 98
|
—
|
0.80 Score on a scale
Standard Deviation 1.19
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 99
|
—
|
0.70 Score on a scale
Standard Deviation 1.58
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 100
|
—
|
0.88 Score on a scale
Standard Deviation 1.38
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 101
|
—
|
1.13 Score on a scale
Standard Deviation 1.54
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 102
|
—
|
0.96 Score on a scale
Standard Deviation 1.58
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 103
|
—
|
0.55 Score on a scale
Standard Deviation 1.68
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 104
|
—
|
1.07 Score on a scale
Standard Deviation 1.33
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 105
|
—
|
1.07 Score on a scale
Standard Deviation 1.33
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 106
|
—
|
0.40 Score on a scale
Standard Deviation 0.28
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 107
|
—
|
1.13 Score on a scale
Standard Deviation 1.63
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 108
|
—
|
1.50 Score on a scale
Standard Deviation 1.56
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 109
|
—
|
1.30 Score on a scale
Standard Deviation 1.27
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 110
|
—
|
1.50 Score on a scale
Standard Deviation 1.56
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 111
|
—
|
1.60 Score on a scale
Standard Deviation 1.41
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 112
|
—
|
1.50 Score on a scale
Standard Deviation 1.56
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 113
|
—
|
1.50 Score on a scale
Standard Deviation 1.56
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 114
|
—
|
1.60 Score on a scale
Standard Deviation 1.70
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 115
|
—
|
1.40 Score on a scale
Standard Deviation 1.41
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 116
|
—
|
1.30 Score on a scale
Standard Deviation 1.27
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 117
|
—
|
1.50 Score on a scale
Standard Deviation 1.56
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 118
|
—
|
1.30 Score on a scale
Standard Deviation 1.27
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 119
|
—
|
1.50 Score on a scale
Standard Deviation 1.56
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 120
|
—
|
2.20 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 121
|
—
|
2.40 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 122
|
—
|
2.20 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 123
|
—
|
2.20 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 124
|
—
|
2.20 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 125
|
—
|
2.20 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 126
|
—
|
2.20 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 127
|
—
|
2.20 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 128
|
—
|
2.20 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 129
|
—
|
2.20 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 130
|
—
|
2.20 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Dyspnoea, Week 131
|
—
|
2.20 Score on a scale
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 53
|
0.70 Score on a scale
Standard Deviation 0.76
|
0.38 Score on a scale
Standard Deviation 0.71
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 54
|
0.50 Score on a scale
Standard Deviation 0.41
|
0.07 Score on a scale
Standard Deviation 0.70
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 55
|
0.67 Score on a scale
Standard Deviation 0.29
|
0.12 Score on a scale
Standard Deviation 0.94
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 56
|
0.50 Score on a scale
Standard Deviation 0.41
|
0.14 Score on a scale
Standard Deviation 0.97
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 57
|
0.50 Score on a scale
Standard Deviation 0.50
|
0.15 Score on a scale
Standard Deviation 0.66
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 58
|
0.67 Score on a scale
Standard Deviation 0.29
|
0.08 Score on a scale
Standard Deviation 1.00
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 59
|
0.33 Score on a scale
Standard Deviation 0.58
|
0.06 Score on a scale
Standard Deviation 0.63
|
|
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Cough, Week 60
|
0.75 Score on a scale
Standard Deviation 0.35
|
-0.04 Score on a scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)Population: Analysis was performed for the TC3 or IC3-WT Populations.
TTD in patient-reported lung cancer symptoms, defined as time from randomization to deterioration (10-point change) in any of the following symptom subscales (cough, dyspnea \[multi-item scale\], and chest pain), whichever occurs first, as measured by the EORTC QLQ-LC13. EORTC QLQ-LC13 module incorporates one multi-item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis.
Outcome measures
| Measure |
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
n=98 Participants
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
|
Atezolizumab
n=107 Participants
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
|
|---|---|---|
|
TTD as Assessed Using EORTC QLQ Supplementary Lung Cancer Module (EORTC QLQ-LC13) in the TC3 or IC3-WT Populations
Cough
|
NA Months
Median TTD is not estimable by Kaplan-Meier method due to insufficient observed events.
Lower/Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events
|
NA Months
Interval 21.5 to
Median TTD is not estimable by Kaplan-Meier method due to insufficient number of observed events.
Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
|
|
TTD as Assessed Using EORTC QLQ Supplementary Lung Cancer Module (EORTC QLQ-LC13) in the TC3 or IC3-WT Populations
Dyspnea
|
11.8 Months
Interval 6.8 to 19.5
|
11.1 Months
Interval 7.0 to
Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
|
|
TTD as Assessed Using EORTC QLQ Supplementary Lung Cancer Module (EORTC QLQ-LC13) in the TC3 or IC3-WT Populations
Chest pain
|
NA Months
Median TTD is not estimable by Kaplan-Meier method due to insufficient number of observed events.
Lower/Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
|
NA Months
Median TTD is not estimable by Kaplan-Meier method due to insufficient number of observed events.
Lower/Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
|
SECONDARY outcome
Timeframe: From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months)Population: Analysis was performed for participants with PD-L1 Expression of PD-L1 status by SP263 \>=50%, SP263 \>=25%, SP263 \>=1% in the Intent-to-Treat Wild Type Population.
OS is defined as the time from randomization to death from any cause.
Outcome measures
| Measure |
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
n=210 Participants
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
|
Atezolizumab
n=212 Participants
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
|
|---|---|---|
|
OS in Participants With PD-L1 Expression
SP263 >=50%-WT Population
|
16.1 Months
Interval 9.8 to 17.4
|
19.5 Months
Interval 13.8 to
Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
|
|
OS in Participants With PD-L1 Expression
SP263 >=25%-WT Population
|
12.6 Months
Interval 9.1 to 17.0
|
18.2 Months
Interval 13.3 to
Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
|
|
OS in Participants With PD-L1 Expression
SP263 =1%-WT Population
|
14.0 Months
Interval 9.8 to 16.5
|
17.8 Months
Interval 12.8 to 23.1
|
SECONDARY outcome
Timeframe: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)Population: Analysis was performed for participants with PD-L1 Expression of PD-L1 status by SP263 \>=50%, SP263 \>=25%, SP263 \>=1% in the Intent-to-Treat Wild Type Population.
Investigator-assessed PFS according to RECIST v1.1 in the PD-L1 (defined with SP263 IHC assay)
Outcome measures
| Measure |
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
n=210 Participants
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
|
Atezolizumab
n=212 Participants
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
|
|---|---|---|
|
Investigator-Assessed PFS in Participants With PD-L1 Expression According to RECIST v1.1
SP263 >=50%-WT Population
|
4.9 Months
Interval 4.0 to 5.6
|
7.0 Months
Interval 5.6 to 8.7
|
|
Investigator-Assessed PFS in Participants With PD-L1 Expression According to RECIST v1.1
SP263 >=25%-WT Population
|
4.9 Months
Interval 4.2 to 5.6
|
6.9 Months
Interval 5.6 to 8.4
|
|
Investigator-Assessed PFS in Participants With PD-L1 Expression According to RECIST v1.1
SP263 >=1%-WT Population
|
5.4 Months
Interval 4.4 to 5.7
|
6.8 Months
Interval 5.5 to 8.0
|
SECONDARY outcome
Timeframe: From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months)Population: Analysis was performed for the bTMB subpopulations in the Intent-to-Treat Wild Type population.
OS is defined as the time from randomization to death from any cause.
Outcome measures
| Measure |
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
n=83 Participants
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
|
Atezolizumab
n=92 Participants
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
|
|---|---|---|
|
OS in Participants With Blood Tumor Mutational Burden (bTMB)
bTMB >=10-WT Population
|
10.3 Months
Interval 7.1 to 16.9
|
11.2 Months
Interval 7.9 to
Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
|
|
OS in Participants With Blood Tumor Mutational Burden (bTMB)
bTMB >=16-WT Population
|
8.5 Months
Interval 5.8 to
Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
|
13.9 Months
Interval 10.8 to
Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
|
|
OS in Participants With Blood Tumor Mutational Burden (bTMB)
bTMB >=20-WT Population
|
10.5 Months
Interval 5.8 to
Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
|
17.2 Months
Interval 10.8 to
Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
|
SECONDARY outcome
Timeframe: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)Population: Analysis was performed for participants with bTMB \>=10 Intent-to-treat Wild Type Population.
PFS according to RECIST v1.1 in the bTMB subpopulations.
Outcome measures
| Measure |
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
n=83 Participants
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
|
Atezolizumab
n=92 Participants
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
|
|---|---|---|
|
Investigator-Assessed PFS in Participants With bTMB According to RECIST v1.1
bTMB >=10-WT Population
|
4.3 Months
Interval 3.1 to 5.4
|
5.5 Months
Interval 2.8 to 6.8
|
|
Investigator-Assessed PFS in Participants With bTMB According to RECIST v1.1
bTMB >=16-WT Population
|
4.4 Months
Interval 2.8 to 5.7
|
6.8 Months
Interval 4.3 to 11.6
|
|
Investigator-Assessed PFS in Participants With bTMB According to RECIST v1.1
bTMB >=20-WT Population
|
5.2 Months
Interval 3.2 to 6.4
|
6.8 Months
Interval 4.3 to 17.2
|
SECONDARY outcome
Timeframe: Prior to infusion (0 hour) on Day 1 of Cycles 2, 3, 4, 8, 16, and every eighth cycle thereafter, and at treatment discontinuation until data cut-off on 10 September 2018 (up to approximately 38 months) (cycle duration = 21 days)Population: PK analyses was based on PK observations from all randomized participants who received atezolizumab and provided at least one PK sample that was evaluable.
Outcome measures
| Measure |
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
n=256 Participants
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
|
Atezolizumab
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
|
|---|---|---|
|
Minimum Observed Serum Concentration (Cmin) of Atezolizumab
Cycle 48 Day 1
|
555 micrograms per milliliter (μg/ mL)
Standard Deviation NA
Not estimable because there is only 1 participant.
|
—
|
|
Minimum Observed Serum Concentration (Cmin) of Atezolizumab
Treatment Discontinuation Visit
|
121 micrograms per milliliter (μg/ mL)
Standard Deviation 88.8
|
—
|
|
Minimum Observed Serum Concentration (Cmin) of Atezolizumab
Cycle 2 Day 1
|
76.7 micrograms per milliliter (μg/ mL)
Standard Deviation 57.6
|
—
|
|
Minimum Observed Serum Concentration (Cmin) of Atezolizumab
Cycle 3 Day 1
|
121 micrograms per milliliter (μg/ mL)
Standard Deviation 57.7
|
—
|
|
Minimum Observed Serum Concentration (Cmin) of Atezolizumab
Cycle 4 Day 1
|
154 micrograms per milliliter (μg/ mL)
Standard Deviation 90.1
|
—
|
|
Minimum Observed Serum Concentration (Cmin) of Atezolizumab
Cycle 8 Day 1
|
201 micrograms per milliliter (μg/ mL)
Standard Deviation 98.6
|
—
|
|
Minimum Observed Serum Concentration (Cmin) of Atezolizumab
Cycle 16 Day 1
|
213 micrograms per milliliter (μg/ mL)
Standard Deviation 102
|
—
|
|
Minimum Observed Serum Concentration (Cmin) of Atezolizumab
Cycle 24 Day 1
|
245 micrograms per milliliter (μg/ mL)
Standard Deviation 128
|
—
|
|
Minimum Observed Serum Concentration (Cmin) of Atezolizumab
Cycle 32 Day 1
|
276 micrograms per milliliter (μg/ mL)
Standard Deviation 110
|
—
|
|
Minimum Observed Serum Concentration (Cmin) of Atezolizumab
Cycle 40 Day 1
|
252 micrograms per milliliter (μg/ mL)
Standard Deviation 160
|
—
|
SECONDARY outcome
Timeframe: 0 hour (predose) and 30 minutes after atezolizumab infusion on Day 1 (infusion duration = up to 1 hour)Population: PK analyses was based on PK observations from all randomized participants who received atezolizumab and provided at least one PK sample that was evaluable.
Outcome measures
| Measure |
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
n=270 Participants
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
|
Atezolizumab
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
|
|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of Atezolizumab
|
411 micrograms per milliliter (μg/ mL)
Standard Deviation 163
|
—
|
SECONDARY outcome
Timeframe: Baseline up to until data cut-off on 8 March 2022 (up to approximately 79.5 months)Population: Safety analyses included treated participants, defined as randomized participants who received any amount of study treatment.
Percentage of participants with at least one adverse event.
Outcome measures
| Measure |
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
n=263 Participants
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
|
Atezolizumab
n=286 Participants
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
|
|---|---|---|
|
Percentage of Participants With at Least One Adverse Event
|
95.1 Percentage of participants
|
92.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)Population: The baseline ADA-evaluable population included participants who had a baseline ADA result and had received at least one dose of atezolizumab. The post-baseline ADA evaluable population included participants who had at least one post-baseline ADA result and had received at least one dose of atezolizumab.
Outcome measures
| Measure |
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
n=282 Participants
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
|
Atezolizumab
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
|
|---|---|---|
|
Percentage of Participants With Anti-therapeutic Antibodies (ATAs)
Baseline evaluable participants
|
1.4 Percentage of participants
|
—
|
|
Percentage of Participants With Anti-therapeutic Antibodies (ATAs)
Post-baseline evaluable participants
|
24.3 Percentage of participants
|
—
|
Adverse Events
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
Serious events: 77 serious events
Other events: 230 other events
Deaths: 211 deaths
Atezolizumab
Serious events: 97 serious events
Other events: 238 other events
Deaths: 201 deaths
Serious adverse events
| Measure |
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
n=263 participants at risk
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
|
Atezolizumab
n=286 participants at risk
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.8%
10/263 • Number of events 15 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.9%
5/263 • Number of events 5 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.9%
5/263 • Number of events 5 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.1%
3/263 • Number of events 3 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.4%
9/263 • Number of events 10 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.70%
2/286 • Number of events 2 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 2 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
Autoimmune myocarditis
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.76%
2/263 • Number of events 2 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Endocrine disorders
Glucocorticoid deficiency
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Eye disorders
Cataract
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.76%
2/263 • Number of events 2 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
Asthenia
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
Death
|
1.1%
3/263 • Number of events 3 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.70%
2/286 • Number of events 2 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
Fatigue
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.0%
3/286 • Number of events 3 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.4%
4/286 • Number of events 5 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
Swelling
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.70%
2/286 • Number of events 2 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.70%
2/286 • Number of events 2 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Immune system disorders
Drug hypersensitivity
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 2 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Immune system disorders
Immune system disorder
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 2 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Abscess neck
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Bacteraemia
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Bronchitis bacterial
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 2 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Escherichia sepsis
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Gangrene
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.70%
2/286 • Number of events 3 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.1%
3/263 • Number of events 3 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.0%
3/286 • Number of events 3 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Muscle abscess
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Mycotic endophthalmitis
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Pleural infection
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Pneumonia
|
5.3%
14/263 • Number of events 14 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
5.2%
15/286 • Number of events 25 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Pneumonia bacterial
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Pulmonary sepsis
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Respiratory tract infection
|
1.5%
4/263 • Number of events 5 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.0%
3/286 • Number of events 3 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Sepsis
|
0.76%
2/263 • Number of events 2 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.70%
2/286 • Number of events 2 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Subcutaneous abscess
|
0.38%
1/263 • Number of events 2 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Tuberculosis
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.70%
2/286 • Number of events 2 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
Platelet count decreased
|
0.38%
1/263 • Number of events 2 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.76%
2/263 • Number of events 2 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.0%
3/286 • Number of events 3 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.0%
3/286 • Number of events 3 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
Neurological decompensation
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
Seizure
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Product Issues
Device occlusion
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Product Issues
Thrombosis in device
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Psychiatric disorders
Delirium
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
Ketonuria
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.76%
2/263 • Number of events 2 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
2.8%
8/286 • Number of events 14 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.70%
2/286 • Number of events 2 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.5%
4/263 • Number of events 4 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
2.1%
6/286 • Number of events 10 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
2.1%
6/286 • Number of events 6 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
Autoimmune dermatitis
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 2 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
Extremity necrosis
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
Thrombophlebitis
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Melaena
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Bacterial colitis
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Infection
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.70%
2/286 • Number of events 2 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Biliary neoplasm
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
Varicose vein
|
0.38%
1/263 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.70%
2/286 • Number of events 2 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Post-acute COVID-19 syndrome
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Langerhans' cell histiocytosis
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
Vein disorder
|
0.00%
0/263 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
Other adverse events
| Measure |
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
n=263 participants at risk
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
|
Atezolizumab
n=286 participants at risk
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
45.6%
120/263 • Number of events 153 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
17.5%
50/286 • Number of events 73 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.0%
21/263 • Number of events 31 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.4%
4/286 • Number of events 6 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
27.0%
71/263 • Number of events 128 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.7%
5/286 • Number of events 7 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
15.2%
40/263 • Number of events 62 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
2.8%
8/286 • Number of events 8 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Endocrine disorders
Hypothyroidism
|
1.1%
3/263 • Number of events 3 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
9.4%
27/286 • Number of events 28 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Constipation
|
22.1%
58/263 • Number of events 75 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
14.7%
42/286 • Number of events 48 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.4%
30/263 • Number of events 39 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
13.6%
39/286 • Number of events 55 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Nausea
|
33.5%
88/263 • Number of events 148 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
14.7%
42/286 • Number of events 49 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
5.3%
14/263 • Number of events 16 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
4.2%
12/286 • Number of events 14 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
Vomiting
|
12.9%
34/263 • Number of events 45 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
7.3%
21/286 • Number of events 27 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
Asthenia
|
17.9%
47/263 • Number of events 66 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
14.3%
41/286 • Number of events 58 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
Chest pain
|
3.8%
10/263 • Number of events 10 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
7.3%
21/286 • Number of events 28 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
Fatigue
|
17.9%
47/263 • Number of events 57 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
15.4%
44/286 • Number of events 47 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
Pyrexia
|
9.5%
25/263 • Number of events 30 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
14.0%
40/286 • Number of events 58 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Nasopharyngitis
|
2.7%
7/263 • Number of events 8 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
7.7%
22/286 • Number of events 37 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
Alanine aminotransferase increased
|
6.1%
16/263 • Number of events 17 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
10.5%
30/286 • Number of events 34 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
4.2%
11/263 • Number of events 12 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
10.1%
29/286 • Number of events 35 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
Blood creatinine increased
|
10.3%
27/263 • Number of events 33 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
3.1%
9/286 • Number of events 12 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
Neutrophil count decreased
|
7.2%
19/263 • Number of events 27 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/286 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
Platelet count decreased
|
8.0%
21/263 • Number of events 30 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.35%
1/286 • Number of events 1 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
Weight decreased
|
5.7%
15/263 • Number of events 15 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
8.7%
25/286 • Number of events 27 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
White blood cell count decreased
|
5.3%
14/263 • Number of events 24 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.0%
3/286 • Number of events 17 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
19.0%
50/263 • Number of events 61 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
17.5%
50/286 • Number of events 65 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.6%
12/263 • Number of events 19 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
6.6%
19/286 • Number of events 29 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
8/263 • Number of events 8 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
10.8%
31/286 • Number of events 46 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
14/263 • Number of events 15 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
9.1%
26/286 • Number of events 28 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
Headache
|
6.8%
18/263 • Number of events 20 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
10.8%
31/286 • Number of events 32 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Psychiatric disorders
Insomnia
|
5.7%
15/263 • Number of events 16 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
7.7%
22/286 • Number of events 25 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.5%
25/263 • Number of events 27 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
12.6%
36/286 • Number of events 48 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.9%
26/263 • Number of events 32 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
14.3%
41/286 • Number of events 48 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.4%
9/263 • Number of events 12 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
8.0%
23/286 • Number of events 25 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.1%
16/263 • Number of events 16 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.0%
3/286 • Number of events 3 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.5%
4/263 • Number of events 4 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
8.7%
25/286 • Number of events 33 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.0%
8/263 • Number of events 8 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
8.0%
23/286 • Number of events 26 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
Oedema peripheral
|
6.1%
16/263 • Number of events 18 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
4.5%
13/286 • Number of events 14 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.7%
15/263 • Number of events 17 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
4.2%
12/286 • Number of events 18 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
Dizziness
|
5.3%
14/263 • Number of events 18 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
3.1%
9/286 • Number of events 9 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
Pneumonia
|
3.0%
8/263 • Number of events 8 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
5.2%
15/286 • Number of events 17 • From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER