Trial Outcomes & Findings for A Study of Atezolizumab in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Participants Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower 132) (NCT NCT02657434)

NCT ID: NCT02657434

Last Updated: 2023-11-21

Results Overview

PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator using RECIST v1.1 or death from any cause, whichever occurred first.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

578 participants

Primary outcome timeframe

Randomization up to approximately 39 months

Results posted on

2023-11-21

Participant Flow

The study is considered "Completed" because the planned study activities and analyses have been performed.

Participant milestones

Participant milestones
Measure
Arm B (Carboplatin or Cisplatin + Pemetrexed)
Participants received IV infusion of 500 mg/m\^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m\^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Overall Study
STARTED
286
292
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
286
292

Reasons for withdrawal

Reasons for withdrawal
Measure
Arm B (Carboplatin or Cisplatin + Pemetrexed)
Participants received IV infusion of 500 mg/m\^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m\^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Overall Study
Study Terminated By Sponsor
64
82
Overall Study
Death
189
190
Overall Study
Lost to Follow-up
2
2
Overall Study
Randomization by Error
2
0
Overall Study
Withdrawal by Subject
28
17
Overall Study
Protocol Violation
1
0
Overall Study
Physician Decision
0
1

Baseline Characteristics

A Study of Atezolizumab in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Participants Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower 132)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Arm B (Carboplatin or Cisplatin + Pemetrexed)
n=286 Participants
Participants received IV infusion of 500 mg/m\^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase will begin maintenance therapy. Participants will receive IV infusion of 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
n=292 Participants
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m\^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Total
n=578 Participants
Total of all reporting groups
Age, Continuous
61.8 Years
STANDARD_DEVIATION 9.4 • n=5 Participants
63.3 Years
STANDARD_DEVIATION 9.4 • n=7 Participants
62.6 Years
STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male
Female
94 Participants
n=5 Participants
100 Participants
n=7 Participants
194 Participants
n=5 Participants
Sex: Female, Male
Male
192 Participants
n=5 Participants
192 Participants
n=7 Participants
384 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
21 Participants
n=5 Participants
17 Participants
n=7 Participants
38 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
241 Participants
n=5 Participants
243 Participants
n=7 Participants
484 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
24 Participants
n=5 Participants
32 Participants
n=7 Participants
56 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
Asian
65 Participants
n=5 Participants
71 Participants
n=7 Participants
136 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
4 Participants
n=5 Participants
2 Participants
n=7 Participants
6 Participants
n=5 Participants
Race (NIH/OMB)
White
203 Participants
n=5 Participants
193 Participants
n=7 Participants
396 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
13 Participants
n=5 Participants
25 Participants
n=7 Participants
38 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Randomization up to approximately 39 months

Population: The ITT population was defined as all randomized patients, whether or not the patients received the assigned treatment.

PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator using RECIST v1.1 or death from any cause, whichever occurred first.

Outcome measures

Outcome measures
Measure
Arm B (Carboplatin or Cisplatin + Pemetrexed)
n=286 Participants
Participants received IV infusion of 500 mg/m\^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
n=292 Participants
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m\^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Progression Free Survival (PFS) as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
5.2 Months
Interval 4.3 to 5.6
7.7 Months
Interval 6.7 to 8.5

PRIMARY outcome

Timeframe: Randomization up to approximately 39 months

Population: The ITT population was defined as all randomized patients, whether or not the patients received the assigned treatment.

OS is defined as time from randomization to death from any cause.

Outcome measures

Outcome measures
Measure
Arm B (Carboplatin or Cisplatin + Pemetrexed)
n=286 Participants
Participants received IV infusion of 500 mg/m\^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
n=292 Participants
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m\^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Overall Survival (OS)
13.6 Months
Interval 11.0 to 15.7
17.5 Months
Interval 13.2 to 19.6

SECONDARY outcome

Timeframe: Year 1

Population: The ITT population was defined as all randomized patients, whether or not the patients received the assigned treatment.

The Overall Survival Rate at the 1-year landmark time point is defined as the probabilities that participants are alive 1-year after randomization.

Outcome measures

Outcome measures
Measure
Arm B (Carboplatin or Cisplatin + Pemetrexed)
n=286 Participants
Participants received IV infusion of 500 mg/m\^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
n=292 Participants
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m\^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Overall Survival Rate at Year 1
55.04 Percentage
Interval 49.21 to 60.87
59.72 Percentage
Interval 54.02 to 65.41

SECONDARY outcome

Timeframe: Year 2

The Overall Survival Rate at the 2-year landmark time point is defined as the probabilities that participants are alive 2-years after randomization.

Outcome measures

Outcome measures
Measure
Arm B (Carboplatin or Cisplatin + Pemetrexed)
n=286 Participants
Participants received IV infusion of 500 mg/m\^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
n=292 Participants
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m\^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Overall Survival Rate Year 2
34.01 Percentage
Interval 28.4 to 39.62
39.13 Percentage
Interval 33.44 to 44.81

SECONDARY outcome

Timeframe: Randomization up to approximately 25 months

Population: The ITT population was defined as all randomized patients, whether or not the patients received the assigned treatment.

An objective response is defined as either an unconfirmed CR or a PR, as determined by the investigator using RECIST v1.1. Objective Response Rate is defined as the proportion of patients who had an objective response.

Outcome measures

Outcome measures
Measure
Arm B (Carboplatin or Cisplatin + Pemetrexed)
n=286 Participants
Participants received IV infusion of 500 mg/m\^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
n=292 Participants
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m\^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Percentage of Participants With an Objective Response (Complete Response [CR] or Partial Response [PR]) Assessed by the Investigator Using RECIST V1.1
Responders
37.4 Percentage of Participants
51.7 Percentage of Participants
Percentage of Participants With an Objective Response (Complete Response [CR] or Partial Response [PR]) Assessed by the Investigator Using RECIST V1.1
Non-Responders
62.6 Percentage of Participants
48.3 Percentage of Participants

SECONDARY outcome

Timeframe: Randomization up to approximately 25 months

Population: DOR was assessed in participants who had an objective response as determined by the investigator using RECIST v1.1.

DOR is defined as the time interval from the date of the first occurrence of a CR or PR (whichever status is recorded first) until the first date that progressive disease or death is documented, whichever occurs first.

Outcome measures

Outcome measures
Measure
Arm B (Carboplatin or Cisplatin + Pemetrexed)
n=286 Participants
Participants received IV infusion of 500 mg/m\^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
n=292 Participants
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m\^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1
6.4 Months
Interval 4.4 to 7.6
9.5 Months
Interval 6.9 to 12.2

SECONDARY outcome

Timeframe: Baseline up to 3 and 6 months after disease progression or loss of clinical benefit (up to approximately 25 months)

Population: ITT population with a non-missing baseline and at least a post-baseline PRO assessment (i.e., PRO evaluable population).

EORTC QLQ-C30 is a validated and reliable self-report measure that consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health/quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). EORTC QLQ-C30 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however a high score for a symptom scale or item represents a high level of symptomatology or problems. A ≥10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al. 1998).

Outcome measures

Outcome measures
Measure
Arm B (Carboplatin or Cisplatin + Pemetrexed)
n=232 Participants
Participants received IV infusion of 500 mg/m\^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
n=242 Participants
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m\^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 3
-1.95 Units on a scale
Standard Deviation 23.97
-1.39 Units on a scale
Standard Deviation 25.17
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 6
-1.23 Units on a scale
Standard Deviation 23.16
-4.71 Units on a scale
Standard Deviation 26.66
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 9
0.20 Units on a scale
Standard Deviation 26.34
-6.33 Units on a scale
Standard Deviation 26.62
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 12
-0.91 Units on a scale
Standard Deviation 27.57
-3.39 Units on a scale
Standard Deviation 29.10
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 15
-1.67 Units on a scale
Standard Deviation 28.92
-2.44 Units on a scale
Standard Deviation 28.73
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 18
-2.12 Units on a scale
Standard Deviation 24.85
-3.44 Units on a scale
Standard Deviation 30.43
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 21
-5.67 Units on a scale
Standard Deviation 29.61
-2.89 Units on a scale
Standard Deviation 31.83
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 24
-2.75 Units on a scale
Standard Deviation 28.74
-2.45 Units on a scale
Standard Deviation 31.85
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 27
-2.53 Units on a scale
Standard Deviation 31.47
-1.32 Units on a scale
Standard Deviation 27.13
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 30
-1.25 Units on a scale
Standard Deviation 32.45
-2.71 Units on a scale
Standard Deviation 28.50
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 33
-1.83 Units on a scale
Standard Deviation 27.15
-3.74 Units on a scale
Standard Deviation 30.14
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 36
-3.83 Units on a scale
Standard Deviation 30.49
-6.67 Units on a scale
Standard Deviation 31.49
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 39
-1.67 Units on a scale
Standard Deviation 31.55
-8.42 Units on a scale
Standard Deviation 29.16
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 42
-3.27 Units on a scale
Standard Deviation 28.48
-9.12 Units on a scale
Standard Deviation 28.12
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 45
-6.25 Units on a scale
Standard Deviation 32.00
-2.11 Units on a scale
Standard Deviation 30.82
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 48
-5.13 Units on a scale
Standard Deviation 32.03
-7.41 Units on a scale
Standard Deviation 26.87
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 51
-14.81 Units on a scale
Standard Deviation 30.28
-2.92 Units on a scale
Standard Deviation 26.09
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 54
-9.68 Units on a scale
Standard Deviation 35.69
-2.78 Units on a scale
Standard Deviation 27.26
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 57
-7.69 Units on a scale
Standard Deviation 28.76
-5.63 Units on a scale
Standard Deviation 28.72
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 60
-11.11 Units on a scale
Standard Deviation 25.57
0.00 Units on a scale
Standard Deviation 25.43
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 63
-7.69 Units on a scale
Standard Deviation 14.62
-5.13 Units on a scale
Standard Deviation 23.62
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 66
-9.52 Units on a scale
Standard Deviation 16.27
-1.80 Units on a scale
Standard Deviation 24.78
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 69
-16.67 Units on a scale
Standard Deviation 18.26
-3.57 Units on a scale
Standard Deviation 24.58
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 72
-4.17 Units on a scale
Standard Deviation 27.82
0.00 Units on a scale
Standard Deviation 27.22
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 75
-6.67 Units on a scale
Standard Deviation 14.91
-5.80 Units on a scale
Standard Deviation 19.21
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 78
0.00 Units on a scale
Standard Deviation 0.00
-4.76 Units on a scale
Standard Deviation 25.68
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 81
0.00 Units on a scale
Standard Deviation 0.00
-11.11 Units on a scale
Standard Deviation 23.57
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 84
0.00 Units on a scale
Standard Deviation 0.00
-4.17 Units on a scale
Standard Deviation 21.36
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 87
0.00 Units on a scale
Standard Deviation NA
Only 1 participant.
8.33 Units on a scale
Standard Deviation 16.67
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 90
0.00 Units on a scale
Standard Deviation NA
Only 1 participant.
0.00 Units on a scale
Standard Deviation 0.00
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Week 93
0.00 Units on a scale
Standard Deviation NA
Only 1 participant.
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Survival Follow-Up Week 12
9.20 Units on a scale
Standard Deviation 35.52
8.00 Units on a scale
Standard Deviation 42.25
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Dyspnoea: Survival Follow-Up Week 24
5.26 Units on a scale
Standard Deviation 25.49
-14.29 Units on a scale
Standard Deviation 17.82

SECONDARY outcome

Timeframe: Baseline up to 3 and 6 months after disease progression or loss of clinical benefit (up to approximately 25 months)

Population: ITT population with a non-missing baseline and at least a post-baseline PRO assessment (i.e., PRO evaluable population).

The EORTC QLQ-LC13 module incorporates one multiple item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. The EORTC QLQ-LC13 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however, a high score for a symptom scale or item represents a high level of symptomatology or problems. A≥10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al. 1998).

Outcome measures

Outcome measures
Measure
Arm B (Carboplatin or Cisplatin + Pemetrexed)
n=230 Participants
Participants received IV infusion of 500 mg/m\^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
n=234 Participants
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m\^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 3
-2.50 Units on a scale
Standard Deviation 25.37
-3.41 Units on a scale
Standard Deviation 26.90
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 6
-3.57 Units on a scale
Standard Deviation 27.20
-9.82 Units on a scale
Standard Deviation 26.50
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 9
-1.85 Units on a scale
Standard Deviation 24.43
-8.29 Units on a scale
Standard Deviation 31.37
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 12
-3.91 Units on a scale
Standard Deviation 28.46
-10.71 Units on a scale
Standard Deviation 31.66
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 15
-6.33 Units on a scale
Standard Deviation 30.39
-11.53 Units on a scale
Standard Deviation 29.05
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 18
-4.00 Units on a scale
Standard Deviation 26.97
-11.63 Units on a scale
Standard Deviation 27.92
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 21
-6.00 Units on a scale
Standard Deviation 27.78
-10.50 Units on a scale
Standard Deviation 30.76
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 24
-4.81 Units on a scale
Standard Deviation 28.05
-10.03 Units on a scale
Standard Deviation 33.08
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 27
-3.85 Units on a scale
Standard Deviation 26.85
-11.65 Units on a scale
Standard Deviation 34.40
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 30
0.42 Units on a scale
Standard Deviation 29.76
-11.39 Units on a scale
Standard Deviation 31.31
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 33
-0.46 Units on a scale
Standard Deviation 26.53
-11.97 Units on a scale
Standard Deviation 30.91
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 36
-6.11 Units on a scale
Standard Deviation 31.59
-12.94 Units on a scale
Standard Deviation 30.33
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 39
-5.00 Units on a scale
Standard Deviation 30.58
-13.41 Units on a scale
Standard Deviation 32.43
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 42
-8.97 Units on a scale
Standard Deviation 27.31
-14.70 Units on a scale
Standard Deviation 29.68
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 45
-13.19 Units on a scale
Standard Deviation 28.13
-14.72 Units on a scale
Standard Deviation 27.83
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 48
-7.69 Units on a scale
Standard Deviation 31.96
-13.92 Units on a scale
Standard Deviation 32.29
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 51
-17.59 Units on a scale
Standard Deviation 25.80
-10.97 Units on a scale
Standard Deviation 34.48
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 54
-17.20 Units on a scale
Standard Deviation 27.04
-13.81 Units on a scale
Standard Deviation 33.81
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 57
-11.54 Units on a scale
Standard Deviation 22.98
-13.53 Units on a scale
Standard Deviation 29.33
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 60
-14.04 Units on a scale
Standard Deviation 27.92
-10.71 Units on a scale
Standard Deviation 31.21
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 63
-10.26 Units on a scale
Standard Deviation 21.01
-12.82 Units on a scale
Standard Deviation 27.16
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 66
-9.52 Units on a scale
Standard Deviation 25.20
-12.61 Units on a scale
Standard Deviation 28.71
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 69
-11.11 Units on a scale
Standard Deviation 27.22
-11.90 Units on a scale
Standard Deviation 30.38
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 72
-8.33 Units on a scale
Standard Deviation 23.57
-16.67 Units on a scale
Standard Deviation 30.43
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 75
-13.33 Units on a scale
Standard Deviation 18.26
-18.84 Units on a scale
Standard Deviation 28.12
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 78
-16.67 Units on a scale
Standard Deviation 23.57
-23.81 Units on a scale
Standard Deviation 27.51
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 81
-16.67 Units on a scale
Standard Deviation 23.57
-18.52 Units on a scale
Standard Deviation 33.79
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 84
-33.33 Units on a scale
Standard Deviation 0.00
-29.17 Units on a scale
Standard Deviation 27.82
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 87
0.00 Units on a scale
Standard Deviation NA
Only 1 participant.
-25.00 Units on a scale
Standard Deviation 31.91
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 90
-33.33 Units on a scale
Standard Deviation NA
Only 1 participant.
-16.67 Units on a scale
Standard Deviation 23.57
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Week 93
0.00 Units on a scale
Standard Deviation NA
Only 1 participant.
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Time of First Pd
-6.01 Units on a scale
Standard Deviation 30.13
-10.48 Units on a scale
Standard Deviation 28.68
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Time of Last Tx Dose
-5.19 Units on a scale
Standard Deviation 28.05
-8.13 Units on a scale
Standard Deviation 28.78
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Survival Follow-Up Week 12
3.57 Units on a scale
Standard Deviation 29.17
-6.94 Units on a scale
Standard Deviation 34.02
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Coughing: Survival Follow-Up Week 24
-8.77 Units on a scale
Standard Deviation 24.45
-14.29 Units on a scale
Standard Deviation 32.53
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 3
0.21 Units on a scale
Standard Deviation 18.69
-1.41 Units on a scale
Standard Deviation 17.68
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 6
0.12 Units on a scale
Standard Deviation 17.13
-1.17 Units on a scale
Standard Deviation 18.85
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 9
0.89 Units on a scale
Standard Deviation 20.68
-3.34 Units on a scale
Standard Deviation 18.65
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 12
1.15 Units on a scale
Standard Deviation 21.82
-0.46 Units on a scale
Standard Deviation 21.76
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 15
0.00 Units on a scale
Standard Deviation 21.30
-1.12 Units on a scale
Standard Deviation 20.78
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 18
-1.07 Units on a scale
Standard Deviation 18.90
-3.88 Units on a scale
Standard Deviation 21.92
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 21
-3.56 Units on a scale
Standard Deviation 22.77
-1.45 Units on a scale
Standard Deviation 21.85
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 24
-2.29 Units on a scale
Standard Deviation 21.75
-0.42 Units on a scale
Standard Deviation 23.82
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 27
-0.71 Units on a scale
Standard Deviation 22.32
-2.08 Units on a scale
Standard Deviation 19.83
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 30
1.25 Units on a scale
Standard Deviation 22.57
-2.78 Units on a scale
Standard Deviation 20.33
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 33
0.77 Units on a scale
Standard Deviation 21.45
-3.02 Units on a scale
Standard Deviation 22.82
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 36
-1.11 Units on a scale
Standard Deviation 20.93
-2.91 Units on a scale
Standard Deviation 23.70
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 39
1.30 Units on a scale
Standard Deviation 26.91
-4.95 Units on a scale
Standard Deviation 22.31
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 42
-0.43 Units on a scale
Standard Deviation 22.65
-6.33 Units on a scale
Standard Deviation 18.64
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 45
-2.08 Units on a scale
Standard Deviation 26.60
-3.61 Units on a scale
Standard Deviation 21.36
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 48
-4.56 Units on a scale
Standard Deviation 24.94
-5.34 Units on a scale
Standard Deviation 21.49
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 51
-9.88 Units on a scale
Standard Deviation 21.87
-1.69 Units on a scale
Standard Deviation 18.41
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 54
-6.45 Units on a scale
Standard Deviation 24.47
-1.90 Units on a scale
Standard Deviation 19.10
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 57
-2.99 Units on a scale
Standard Deviation 23.42
-4.99 Units on a scale
Standard Deviation 22.99
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 60
-11.11 Units on a scale
Standard Deviation 23.42
-0.40 Units on a scale
Standard Deviation 22.32
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 63
-6.84 Units on a scale
Standard Deviation 15.41
-6.55 Units on a scale
Standard Deviation 23.04
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 66
-9.52 Units on a scale
Standard Deviation 16.27
-4.50 Units on a scale
Standard Deviation 21.98
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 69
-16.67 Units on a scale
Standard Deviation 21.94
-4.76 Units on a scale
Standard Deviation 23.12
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 72
-5.56 Units on a scale
Standard Deviation 19.70
-1.52 Units on a scale
Standard Deviation 24.56
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 75
-6.67 Units on a scale
Standard Deviation 14.91
-6.76 Units on a scale
Standard Deviation 17.64
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 78
0.00 Units on a scale
Standard Deviation 0.00
-3.17 Units on a scale
Standard Deviation 21.09
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 81
11.11 Units on a scale
Standard Deviation 15.71
-9.88 Units on a scale
Standard Deviation 22.53
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 84
0.00 Units on a scale
Standard Deviation 0.00
-6.94 Units on a scale
Standard Deviation 22.17
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 87
0.00 Units on a scale
-2.78 Units on a scale
Standard Deviation 18.98
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 90
0.00 Units on a scale
5.56 Units on a scale
Standard Deviation 23.57
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Week 93
22.22 Units on a scale
Standard Deviation NA
Only 1 participant.
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Time of First PD
2.37 Units on a scale
Standard Deviation 22.05
-0.16 Units on a scale
Standard Deviation 24.48
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Time of Last Tx Dose
3.96 Units on a scale
Standard Deviation 22.74
0.44 Units on a scale
Standard Deviation 21.83
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Survival Follow-Up Week 12
9.92 Units on a scale
Standard Deviation 25.90
13.43 Units on a scale
Standard Deviation 33.73
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Dyspnoea: Survival Follow-Up Week 24
4.68 Units on a scale
Standard Deviation 17.50
4.76 Units on a scale
Standard Deviation 23.00
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 3
-1.25 Units on a scale
Standard Deviation 21.19
0.81 Units on a scale
Standard Deviation 23.67
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 6
0.71 Units on a scale
Standard Deviation 25.15
-6.32 Units on a scale
Standard Deviation 24.39
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 9
0.82 Units on a scale
Standard Deviation 24.63
-4.24 Units on a scale
Standard Deviation 25.57
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 12
-2.07 Units on a scale
Standard Deviation 24.60
-0.60 Units on a scale
Standard Deviation 27.65
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 15
-1.46 Units on a scale
Standard Deviation 24.88
-3.56 Units on a scale
Standard Deviation 25.60
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 18
-3.47 Units on a scale
Standard Deviation 26.38
-3.36 Units on a scale
Standard Deviation 26.77
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 21
-3.33 Units on a scale
Standard Deviation 26.17
-2.74 Units on a scale
Standard Deviation 25.22
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 24
-2.41 Units on a scale
Standard Deviation 26.89
-4.76 Units on a scale
Standard Deviation 29.05
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 27
-5.13 Units on a scale
Standard Deviation 29.95
-2.71 Units on a scale
Standard Deviation 22.82
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 30
-4.17 Units on a scale
Standard Deviation 29.71
-3.06 Units on a scale
Standard Deviation 27.33
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 33
-0.46 Units on a scale
Standard Deviation 29.86
-3.88 Units on a scale
Standard Deviation 28.12
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 36
-1.67 Units on a scale
Standard Deviation 31.55
-2.91 Units on a scale
Standard Deviation 27.26
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 39
-3.89 Units on a scale
Standard Deviation 30.12
-3.99 Units on a scale
Standard Deviation 27.44
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 42
-7.69 Units on a scale
Standard Deviation 29.24
-7.17 Units on a scale
Standard Deviation 26.40
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 45
-6.25 Units on a scale
Standard Deviation 29.70
-5.63 Units on a scale
Standard Deviation 25.02
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 48
-7.69 Units on a scale
Standard Deviation 29.08
-4.64 Units on a scale
Standard Deviation 24.88
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 51
-11.11 Units on a scale
Standard Deviation 28.73
-5.49 Units on a scale
Standard Deviation 24.13
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 54
-7.53 Units on a scale
Standard Deviation 29.45
-4.29 Units on a scale
Standard Deviation 25.33
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 57
-1.28 Units on a scale
Standard Deviation 31.95
-5.80 Units on a scale
Standard Deviation 26.17
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 60
0.00 Units on a scale
Standard Deviation 22.22
-3.57 Units on a scale
Standard Deviation 27.47
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 63
-5.13 Units on a scale
Standard Deviation 18.49
-6.84 Units on a scale
Standard Deviation 25.57
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 66
-4.76 Units on a scale
Standard Deviation 23.00
-4.50 Units on a scale
Standard Deviation 27.40
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 69
-16.67 Units on a scale
Standard Deviation 18.26
-5.95 Units on a scale
Standard Deviation 31.50
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 72
-8.33 Units on a scale
Standard Deviation 23.57
-4.55 Units on a scale
Standard Deviation 23.67
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 75
-6.67 Units on a scale
Standard Deviation 14.91
0.00 Units on a scale
Standard Deviation 20.10
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 78
0.00 Units on a scale
Standard Deviation 0.00
0.00 Units on a scale
Standard Deviation 26.15
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 81
0.00 Units on a scale
Standard Deviation 47.14
7.41 Units on a scale
Standard Deviation 14.70
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 84
0.00 Units on a scale
Standard Deviation 0.00
4.17 Units on a scale
Standard Deviation 21.36
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 87
-33.33 Units on a scale
Standard Deviation NA
Only 1 participant.
8.33 Units on a scale
Standard Deviation 16.67
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 90
-33.33 Units on a scale
Standard Deviation NA
Only 1 participant.
0.00 Units on a scale
Standard Deviation 0.00
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Week 93
0.00 Units on a scale
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Time of First Pd
6.56 Units on a scale
Standard Deviation 22.62
-3.81 Units on a scale
Standard Deviation 29.24
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Time of Last Tx Dose
1.34 Units on a scale
Standard Deviation 25.26
-0.83 Units on a scale
Standard Deviation 26.96
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Survival Follow-Up Week 12
5.95 Units on a scale
Standard Deviation 36.35
-2.78 Units on a scale
Standard Deviation 32.48
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Chest: Survival Follow-Up Week 24
1.75 Units on a scale
Standard Deviation 17.48
-4.76 Units on a scale
Standard Deviation 29.99
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 3
-4.69 Units on a scale
Standard Deviation 25.26
-2.60 Units on a scale
Standard Deviation 24.78
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 6
-4.46 Units on a scale
Standard Deviation 23.14
-5.44 Units on a scale
Standard Deviation 25.19
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 9
-2.88 Units on a scale
Standard Deviation 25.85
-8.09 Units on a scale
Standard Deviation 28.73
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 12
-6.90 Units on a scale
Standard Deviation 23.54
-4.37 Units on a scale
Standard Deviation 27.19
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 15
-3.89 Units on a scale
Standard Deviation 23.24
-7.34 Units on a scale
Standard Deviation 30.15
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 18
-5.07 Units on a scale
Standard Deviation 25.77
-6.26 Units on a scale
Standard Deviation 29.09
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 21
-6.00 Units on a scale
Standard Deviation 21.91
-1.83 Units on a scale
Standard Deviation 28.71
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 24
-2.41 Units on a scale
Standard Deviation 28.16
-5.26 Units on a scale
Standard Deviation 30.11
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 27
-5.56 Units on a scale
Standard Deviation 28.13
-3.79 Units on a scale
Standard Deviation 26.72
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 30
1.25 Units on a scale
Standard Deviation 27.27
-3.33 Units on a scale
Standard Deviation 29.12
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 33
-5.56 Units on a scale
Standard Deviation 25.02
-1.94 Units on a scale
Standard Deviation 27.54
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 36
-1.67 Units on a scale
Standard Deviation 30.33
-3.24 Units on a scale
Standard Deviation 31.49
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 39
-5.00 Units on a scale
Standard Deviation 30.58
-3.99 Units on a scale
Standard Deviation 30.80
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 42
0.00 Units on a scale
Standard Deviation 28.77
-8.60 Units on a scale
Standard Deviation 25.49
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 45
-0.69 Units on a scale
Standard Deviation 27.06
-6.06 Units on a scale
Standard Deviation 28.47
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 48
-1.71 Units on a scale
Standard Deviation 27.52
-4.22 Units on a scale
Standard Deviation 29.89
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 51
-2.78 Units on a scale
Standard Deviation 25.67
-3.38 Units on a scale
Standard Deviation 27.53
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 54
-1.08 Units on a scale
Standard Deviation 21.92
-6.19 Units on a scale
Standard Deviation 25.56
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 57
-1.28 Units on a scale
Standard Deviation 22.07
-2.90 Units on a scale
Standard Deviation 26.65
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 60
-5.26 Units on a scale
Standard Deviation 20.07
-4.17 Units on a scale
Standard Deviation 27.75
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 63
-5.13 Units on a scale
Standard Deviation 18.49
-3.42 Units on a scale
Standard Deviation 27.35
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 66
4.76 Units on a scale
Standard Deviation 12.60
-1.80 Units on a scale
Standard Deviation 31.37
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 69
0.00 Units on a scale
Standard Deviation 0.00
-7.14 Units on a scale
Standard Deviation 22.87
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 72
-8.33 Units on a scale
Standard Deviation 15.43
-7.58 Units on a scale
Standard Deviation 27.08
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 75
-6.67 Units on a scale
Standard Deviation 14.91
-8.70 Units on a scale
Standard Deviation 25.06
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 78
0.00 Units on a scale
Standard Deviation 0.00
-2.38 Units on a scale
Standard Deviation 24.33
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 81
0.00 Units on a scale
Standard Deviation 0.00
3.70 Units on a scale
Standard Deviation 11.11
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 84
0.00 Units on a scale
Standard Deviation 0.00
4.17 Units on a scale
Standard Deviation 21.36
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 87
0.00 Units on a scale
Standard Deviation NA
Only 1 participant.
-16.67 Units on a scale
Standard Deviation 33.33
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 90
0.00 Units on a scale
Standard Deviation NA
Only 1 participant.
0.00 Units on a scale
Standard Deviation 0.00
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Week 93
0.00 Units on a scale
Standard Deviation NA
Only 1 participant.
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Time of First Pd
2.19 Units on a scale
Standard Deviation 28.46
1.90 Units on a scale
Standard Deviation 25.94
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder: Time of Last Tx Dose
-0.50 Units on a scale
Standard Deviation 27.11
0.33 Units on a scale
Standard Deviation 30.55
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder:Survival Follow-Up Week 12
13.10 Units on a scale
Standard Deviation 30.55
5.56 Units on a scale
Standard Deviation 40.13
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Pain In Arm Or Shoulder:Survival Follow-Up Week 24
1.75 Units on a scale
Standard Deviation 28.27
0.00 Units on a scale
Standard Deviation 0.00

SECONDARY outcome

Timeframe: Baseline up to 3 and 6 months after disease progression or loss of clinical benefit (up to approximately 25 months)

Population: ITT population with a non-missing baseline and at least a post-baseline PRO assessment (i.e., PRO evaluable population).

Change from baseline per SILC scale will be analyzed for each lung cancer symptoms scores. SILC questionnaire comprises 3 individual symptoms \& are scored at individual symptom level, thus have a dyspnea score, chest pain score, \& cough score. There are a total of 9 questions in SILC questionnaire, each question has a minimum value of 0 \& maximum value of 4. Each individual symptom score is calculated as average of responses for symptom items. 'Chest pain' score is mean of question 1 \& 2, 'Cough' score is mean of question 3 \& 4 and 'Dyspnea' score is mean of question 5 to 9 in SILC questionnaire. An increase in score is suggestive of a worsening in symptomology. A score change of ≥0.3 points for dyspnea \& cough symptom scores is considered to be clinically significant; whereas a score change of≥0.5 points for chest pain score is considered to be clinically significant.

Outcome measures

Outcome measures
Measure
Arm B (Carboplatin or Cisplatin + Pemetrexed)
n=176 Participants
Participants received IV infusion of 500 mg/m\^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
n=200 Participants
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m\^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 91
0.00 Units on a scale
-0.50 Units on a scale
Standard Deviation 0.00
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 45
-0.20 Units on a scale
Standard Deviation 1.24
0.03 Units on a scale
Standard Deviation 0.95
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 46
-0.06 Units on a scale
Standard Deviation 1.18
0.08 Units on a scale
Standard Deviation 0.99
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 47
0.02 Units on a scale
Standard Deviation 1.09
0.09 Units on a scale
Standard Deviation 0.91
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 48
0.02 Units on a scale
Standard Deviation 1.27
0.05 Units on a scale
Standard Deviation 1.00
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 49
-0.09 Units on a scale
Standard Deviation 1.07
0.03 Units on a scale
Standard Deviation 0.90
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 50
-0.13 Units on a scale
Standard Deviation 0.99
0.00 Units on a scale
Standard Deviation 1.03
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 51
-0.02 Units on a scale
Standard Deviation 0.77
0.12 Units on a scale
Standard Deviation 0.94
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 52
0.14 Units on a scale
Standard Deviation 1.06
0.00 Units on a scale
Standard Deviation 1.11
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 53
0.13 Units on a scale
Standard Deviation 1.35
-0.01 Units on a scale
Standard Deviation 1.06
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 54
0.11 Units on a scale
Standard Deviation 1.16
-0.08 Units on a scale
Standard Deviation 1.10
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 55
0.12 Units on a scale
Standard Deviation 1.38
0.03 Units on a scale
Standard Deviation 1.14
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 56
0.13 Units on a scale
Standard Deviation 1.46
0.04 Units on a scale
Standard Deviation 1.18
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 57
0.12 Units on a scale
Standard Deviation 1.21
-0.01 Units on a scale
Standard Deviation 1.15
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 58
0.27 Units on a scale
Standard Deviation 0.98
-0.12 Units on a scale
Standard Deviation 1.10
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 59
0.23 Units on a scale
Standard Deviation 0.73
-0.23 Units on a scale
Standard Deviation 1.01
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 60
0.14 Units on a scale
Standard Deviation 0.67
-0.15 Units on a scale
Standard Deviation 1.17
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 61
0.23 Units on a scale
Standard Deviation 0.83
0.00 Units on a scale
Standard Deviation 1.06
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 62
0.46 Units on a scale
Standard Deviation 0.72
-0.04 Units on a scale
Standard Deviation 1.08
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 63
0.25 Units on a scale
Standard Deviation 0.75
-0.06 Units on a scale
Standard Deviation 1.09
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 64
0.15 Units on a scale
Standard Deviation 0.78
0.09 Units on a scale
Standard Deviation 0.95
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 17
0.35 Units on a scale
Standard Deviation 1.04
0.15 Units on a scale
Standard Deviation 1.00
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 18
0.35 Units on a scale
Standard Deviation 0.99
0.22 Units on a scale
Standard Deviation 0.99
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 19
0.30 Units on a scale
Standard Deviation 1.02
0.22 Units on a scale
Standard Deviation 0.97
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 20
0.30 Units on a scale
Standard Deviation 1.09
0.27 Units on a scale
Standard Deviation 1.06
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 21
0.22 Units on a scale
Standard Deviation 1.03
0.22 Units on a scale
Standard Deviation 1.05
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 22
0.16 Units on a scale
Standard Deviation 1.10
0.28 Units on a scale
Standard Deviation 1.03
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 23
0.24 Units on a scale
Standard Deviation 1.05
0.22 Units on a scale
Standard Deviation 1.03
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 24
0.30 Units on a scale
Standard Deviation 0.98
0.24 Units on a scale
Standard Deviation 0.99
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 25
0.50 Units on a scale
Standard Deviation 1.05
0.28 Units on a scale
Standard Deviation 0.99
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 26
0.30 Units on a scale
Standard Deviation 1.05
0.24 Units on a scale
Standard Deviation 1.04
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 27
0.43 Units on a scale
Standard Deviation 1.17
0.24 Units on a scale
Standard Deviation 1.06
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 28
0.46 Units on a scale
Standard Deviation 1.02
0.25 Units on a scale
Standard Deviation 0.97
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 29
0.43 Units on a scale
Standard Deviation 1.06
0.20 Units on a scale
Standard Deviation 1.01
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 30
0.45 Units on a scale
Standard Deviation 1.08
0.21 Units on a scale
Standard Deviation 0.99
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 31
0.35 Units on a scale
Standard Deviation 1.03
0.15 Units on a scale
Standard Deviation 0.99
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 32
0.48 Units on a scale
Standard Deviation 1.03
0.16 Units on a scale
Standard Deviation 1.01
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 33
0.36 Units on a scale
Standard Deviation 0.96
0.17 Units on a scale
Standard Deviation 0.95
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 34
0.47 Units on a scale
Standard Deviation 1.15
0.24 Units on a scale
Standard Deviation 1.04
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 35
0.42 Units on a scale
Standard Deviation 1.00
0.23 Units on a scale
Standard Deviation 1.03
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 36
0.59 Units on a scale
Standard Deviation 1.06
0.22 Units on a scale
Standard Deviation 1.02
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 37
0.53 Units on a scale
Standard Deviation 1.17
0.24 Units on a scale
Standard Deviation 1.03
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 38
0.59 Units on a scale
Standard Deviation 1.06
0.22 Units on a scale
Standard Deviation 1.07
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 39
0.65 Units on a scale
Standard Deviation 1.04
0.19 Units on a scale
Standard Deviation 1.01
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 40
0.62 Units on a scale
Standard Deviation 1.02
0.19 Units on a scale
Standard Deviation 0.95
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 41
0.63 Units on a scale
Standard Deviation 1.01
0.16 Units on a scale
Standard Deviation 0.95
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 42
0.50 Units on a scale
Standard Deviation 1.01
0.17 Units on a scale
Standard Deviation 0.92
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 65
0.11 Units on a scale
Standard Deviation 0.82
-0.03 Units on a scale
Standard Deviation 0.99
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 66
0.42 Units on a scale
Standard Deviation 0.92
0.13 Units on a scale
Standard Deviation 1.05
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 67
0.36 Units on a scale
Standard Deviation 0.85
0.02 Units on a scale
Standard Deviation 1.00
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 68
0.33 Units on a scale
Standard Deviation 0.88
0.12 Units on a scale
Standard Deviation 1.18
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 69
0.07 Units on a scale
Standard Deviation 0.93
-0.05 Units on a scale
Standard Deviation 1.10
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 70
0.25 Units on a scale
Standard Deviation 0.88
0.03 Units on a scale
Standard Deviation 1.11
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 71
0.30 Units on a scale
Standard Deviation 0.97
0.04 Units on a scale
Standard Deviation 1.09
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 72
-0.13 Units on a scale
Standard Deviation 0.25
-0.22 Units on a scale
Standard Deviation 0.94
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 73
0.13 Units on a scale
Standard Deviation 1.31
-0.10 Units on a scale
Standard Deviation 1.01
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 74
0.38 Units on a scale
Standard Deviation 1.11
-0.02 Units on a scale
Standard Deviation 1.14
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 75
0.38 Units on a scale
Standard Deviation 1.11
-0.07 Units on a scale
Standard Deviation 1.14
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 76
0.00 Units on a scale
Standard Deviation 0.50
-0.06 Units on a scale
Standard Deviation 1.20
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 77
-0.25 Units on a scale
Standard Deviation 0.35
-0.21 Units on a scale
Standard Deviation 1.03
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 78
-0.75 Units on a scale
Standard Deviation 0.35
-0.25 Units on a scale
Standard Deviation 1.14
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 79
0.00 Units on a scale
Standard Deviation 0.71
-0.18 Units on a scale
Standard Deviation 1.20
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 80
-0.25 Units on a scale
Standard Deviation 0.35
-0.12 Units on a scale
Standard Deviation 0.96
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 81
-0.25 Units on a scale
Standard Deviation 0.35
-0.25 Units on a scale
Standard Deviation 0.89
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 82
-0.75 Units on a scale
Standard Deviation 0.35
0.00 Units on a scale
Standard Deviation 1.25
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 83
-0.25 Units on a scale
Standard Deviation 0.35
-0.50 Units on a scale
Standard Deviation 1.73
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 84
0.00 Units on a scale
Standard Deviation 0.71
-0.30 Units on a scale
Standard Deviation 1.57
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 85
-1.00 Units on a scale
Standard Deviation NA
Only 1 participant.
-0.20 Units on a scale
Standard Deviation 1.68
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 86
0.00 Units on a scale
Standard Deviation NA
Only 1 participant.
-0.50 Units on a scale
Standard Deviation 1.73
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 87
-1.00 Units on a scale
Standard Deviation NA
Only 1 participant.
0.50 Units on a scale
Standard Deviation 0.87
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 88
-1.00 Units on a scale
Standard Deviation NA
Only 1 participant.
0.00 Units on a scale
Standard Deviation 0.00
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 89
-1.00 Units on a scale
Standard Deviation NA
Only 1 participant.
0.00 Units on a scale
Standard Deviation 0.00
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 90
0.00 Units on a scale
Standard Deviation NA
Only 1 participant.
0.00 Units on a scale
Standard Deviation 0.00
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 91
0.00 Units on a scale
Standard Deviation NA
Only 1 participant.
0.00 Units on a scale
Standard Deviation 0.00
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 92
0.00 Units on a scale
Standard Deviation 0.00
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 93
0.00 Units on a scale
Standard Deviation 0.00
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 94
1.00 Units on a scale
Standard Deviation NA
Only 1 participant.
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 95
0.50 Units on a scale
Standard Deviation NA
Only 1 participant.
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Time of First Pd
0.28 Units on a scale
Standard Deviation 1.06
0.20 Units on a scale
Standard Deviation 0.91
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Time of Last Tx Dose
0.17 Units on a scale
Standard Deviation 1.17
0.13 Units on a scale
Standard Deviation 0.98
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 1
-0.08 Units on a scale
Standard Deviation 0.74
-0.06 Units on a scale
Standard Deviation 0.89
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 2
-0.13 Units on a scale
Standard Deviation 0.73
-0.08 Units on a scale
Standard Deviation 0.90
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 3
-0.05 Units on a scale
Standard Deviation 0.77
-0.07 Units on a scale
Standard Deviation 0.81
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 4
-0.11 Units on a scale
Standard Deviation 0.89
-0.22 Units on a scale
Standard Deviation 0.85
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 5
-0.14 Units on a scale
Standard Deviation 0.83
-0.33 Units on a scale
Standard Deviation 0.89
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 6
-0.16 Units on a scale
Standard Deviation 0.85
-0.33 Units on a scale
Standard Deviation 0.91
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 7
-0.22 Units on a scale
Standard Deviation 0.89
-0.22 Units on a scale
Standard Deviation 0.97
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 8
-0.20 Units on a scale
Standard Deviation 0.89
-0.28 Units on a scale
Standard Deviation 0.98
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 9
-0.17 Units on a scale
Standard Deviation 0.91
-0.29 Units on a scale
Standard Deviation 0.97
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 10
-0.22 Units on a scale
Standard Deviation 0.95
-0.35 Units on a scale
Standard Deviation 1.06
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 11
-0.21 Units on a scale
Standard Deviation 0.99
-0.33 Units on a scale
Standard Deviation 1.02
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 12
-0.13 Units on a scale
Standard Deviation 1.05
-0.40 Units on a scale
Standard Deviation 0.96
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 13
-0.24 Units on a scale
Standard Deviation 1.05
-0.37 Units on a scale
Standard Deviation 1.04
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 14
-0.23 Units on a scale
Standard Deviation 0.98
-0.34 Units on a scale
Standard Deviation 1.03
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 15
-0.11 Units on a scale
Standard Deviation 1.03
-0.33 Units on a scale
Standard Deviation 1.03
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 16
-0.20 Units on a scale
Standard Deviation 1.05
-0.33 Units on a scale
Standard Deviation 1.04
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 17
-0.20 Units on a scale
Standard Deviation 1.11
-0.31 Units on a scale
Standard Deviation 0.99
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 18
-0.19 Units on a scale
Standard Deviation 1.12
-0.31 Units on a scale
Standard Deviation 1.00
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 19
-0.25 Units on a scale
Standard Deviation 1.07
-0.36 Units on a scale
Standard Deviation 1.06
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 20
-0.25 Units on a scale
Standard Deviation 1.16
-0.39 Units on a scale
Standard Deviation 0.99
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 21
-0.19 Units on a scale
Standard Deviation 1.09
-0.36 Units on a scale
Standard Deviation 1.07
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 22
-0.29 Units on a scale
Standard Deviation 1.11
-0.41 Units on a scale
Standard Deviation 1.08
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 23
-0.34 Units on a scale
Standard Deviation 1.07
-0.44 Units on a scale
Standard Deviation 1.04
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 24
-0.27 Units on a scale
Standard Deviation 0.96
-0.29 Units on a scale
Standard Deviation 1.13
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 25
-0.24 Units on a scale
Standard Deviation 1.11
-0.27 Units on a scale
Standard Deviation 1.10
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 26
-0.25 Units on a scale
Standard Deviation 1.16
-0.22 Units on a scale
Standard Deviation 1.22
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 27
-0.19 Units on a scale
Standard Deviation 0.99
-0.32 Units on a scale
Standard Deviation 1.11
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 28
-0.19 Units on a scale
Standard Deviation 1.04
-0.32 Units on a scale
Standard Deviation 1.12
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 29
-0.25 Units on a scale
Standard Deviation 1.13
-0.34 Units on a scale
Standard Deviation 1.11
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 30
-0.08 Units on a scale
Standard Deviation 1.12
-0.34 Units on a scale
Standard Deviation 1.00
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 31
-0.13 Units on a scale
Standard Deviation 1.13
-0.37 Units on a scale
Standard Deviation 0.99
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 32
0.01 Units on a scale
Standard Deviation 1.09
-0.45 Units on a scale
Standard Deviation 0.94
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 33
0.05 Units on a scale
Standard Deviation 1.17
-0.44 Units on a scale
Standard Deviation 0.99
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 34
-0.10 Units on a scale
Standard Deviation 1.09
-0.29 Units on a scale
Standard Deviation 1.02
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 35
-0.27 Units on a scale
Standard Deviation 1.05
-0.32 Units on a scale
Standard Deviation 0.99
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 36
0.01 Units on a scale
Standard Deviation 1.10
-0.31 Units on a scale
Standard Deviation 0.99
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 37
-0.11 Units on a scale
Standard Deviation 1.16
-0.37 Units on a scale
Standard Deviation 1.01
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 38
0.02 Units on a scale
Standard Deviation 1.03
-0.31 Units on a scale
Standard Deviation 1.03
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 39
0.02 Units on a scale
Standard Deviation 1.19
-0.33 Units on a scale
Standard Deviation 0.98
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 40
-0.10 Units on a scale
Standard Deviation 1.15
-0.35 Units on a scale
Standard Deviation 1.07
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 41
-0.27 Units on a scale
Standard Deviation 1.10
-0.30 Units on a scale
Standard Deviation 1.09
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 42
-0.31 Units on a scale
Standard Deviation 1.04
-0.31 Units on a scale
Standard Deviation 1.04
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 43
-0.20 Units on a scale
Standard Deviation 1.04
-0.37 Units on a scale
Standard Deviation 0.98
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 44
0.00 Units on a scale
Standard Deviation 1.04
-0.36 Units on a scale
Standard Deviation 1.03
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 45
-0.18 Units on a scale
Standard Deviation 1.14
-0.41 Units on a scale
Standard Deviation 1.04
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 46
-0.25 Units on a scale
Standard Deviation 1.04
-0.34 Units on a scale
Standard Deviation 1.17
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 47
-0.43 Units on a scale
Standard Deviation 1.09
-0.29 Units on a scale
Standard Deviation 1.17
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 48
-0.26 Units on a scale
Standard Deviation 1.16
-0.38 Units on a scale
Standard Deviation 1.08
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 49
-0.50 Units on a scale
Standard Deviation 1.07
-0.40 Units on a scale
Standard Deviation 1.10
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 50
-0.37 Units on a scale
Standard Deviation 0.84
-0.40 Units on a scale
Standard Deviation 1.06
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 51
-0.45 Units on a scale
Standard Deviation 1.16
-0.15 Units on a scale
Standard Deviation 1.10
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 52
-0.29 Units on a scale
Standard Deviation 1.07
-0.10 Units on a scale
Standard Deviation 1.17
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 53
-0.24 Units on a scale
Standard Deviation 1.21
-0.13 Units on a scale
Standard Deviation 1.17
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 54
-0.27 Units on a scale
Standard Deviation 1.10
-0.16 Units on a scale
Standard Deviation 1.15
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 55
-0.10 Units on a scale
Standard Deviation 1.15
-0.35 Units on a scale
Standard Deviation 1.13
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 56
-0.30 Units on a scale
Standard Deviation 1.14
-0.26 Units on a scale
Standard Deviation 1.17
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 57
-0.41 Units on a scale
Standard Deviation 0.92
-0.25 Units on a scale
Standard Deviation 1.10
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 58
-0.17 Units on a scale
Standard Deviation 1.05
-0.45 Units on a scale
Standard Deviation 0.96
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 59
-0.31 Units on a scale
Standard Deviation 0.93
-0.50 Units on a scale
Standard Deviation 1.02
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 60
-0.55 Units on a scale
Standard Deviation 1.04
-0.52 Units on a scale
Standard Deviation 1.03
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 61
-0.23 Units on a scale
Standard Deviation 1.15
-0.38 Units on a scale
Standard Deviation 1.07
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 62
0.04 Units on a scale
Standard Deviation 1.03
-0.53 Units on a scale
Standard Deviation 1.15
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 63
-0.29 Units on a scale
Standard Deviation 1.18
-0.57 Units on a scale
Standard Deviation 1.10
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 64
-0.45 Units on a scale
Standard Deviation 1.04
-0.49 Units on a scale
Standard Deviation 1.01
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 65
-0.61 Units on a scale
Standard Deviation 0.96
-0.39 Units on a scale
Standard Deviation 0.94
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 66
-0.17 Units on a scale
Standard Deviation 0.82
-0.43 Units on a scale
Standard Deviation 1.18
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 67
-0.64 Units on a scale
Standard Deviation 1.07
-0.47 Units on a scale
Standard Deviation 0.84
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 68
-0.75 Units on a scale
Standard Deviation 0.88
-0.35 Units on a scale
Standard Deviation 1.04
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 69
-0.57 Units on a scale
Standard Deviation 1.10
-0.53 Units on a scale
Standard Deviation 0.90
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 70
-0.83 Units on a scale
Standard Deviation 0.93
-0.43 Units on a scale
Standard Deviation 0.98
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 71
-0.90 Units on a scale
Standard Deviation 0.89
-0.56 Units on a scale
Standard Deviation 1.04
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 72
-1.25 Units on a scale
Standard Deviation 0.50
-0.72 Units on a scale
Standard Deviation 1.15
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 73
-0.63 Units on a scale
Standard Deviation 1.11
-0.77 Units on a scale
Standard Deviation 1.00
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 74
-0.63 Units on a scale
Standard Deviation 1.11
-0.54 Units on a scale
Standard Deviation 0.94
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 75
-0.63 Units on a scale
Standard Deviation 1.11
-0.67 Units on a scale
Standard Deviation 1.00
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 76
-1.00 Units on a scale
Standard Deviation 1.00
-0.65 Units on a scale
Standard Deviation 1.22
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 77
-0.50 Units on a scale
Standard Deviation 0.71
-0.82 Units on a scale
Standard Deviation 1.21
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 78
-1.00 Units on a scale
Standard Deviation 0.00
-0.57 Units on a scale
Standard Deviation 1.04
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 79
-0.25 Units on a scale
Standard Deviation 0.35
-0.64 Units on a scale
Standard Deviation 1.23
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 80
-0.50 Units on a scale
Standard Deviation 0.71
-1.04 Units on a scale
Standard Deviation 1.11
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 81
-0.50 Units on a scale
Standard Deviation 0.71
-0.79 Units on a scale
Standard Deviation 1.05
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 82
-0.50 Units on a scale
Standard Deviation 0.71
-0.89 Units on a scale
Standard Deviation 1.27
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 83
-1.00 Units on a scale
Standard Deviation 0.00
0.13 Units on a scale
Standard Deviation 1.03
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 84
-0.50 Units on a scale
Standard Deviation 0.71
-0.20 Units on a scale
Standard Deviation 1.04
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 85
0.00 Units on a scale
Standard Deviation NA
Only 1 participant.
0.00 Units on a scale
Standard Deviation 0.87
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 86
0.00 Units on a scale
Standard Deviation NA
Only 1 participant.
-0.38 Units on a scale
Standard Deviation 0.48
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 87
0.00 Units on a scale
Standard Deviation NA
Only 1 participant.
-0.83 Units on a scale
Standard Deviation 0.58
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 88
0.00 Units on a scale
Standard Deviation NA
Only 1 participant.
-0.88 Units on a scale
Standard Deviation 0.48
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 89
0.00 Units on a scale
0.00 Units on a scale
Standard Deviation 0.71
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 90
0.00 Units on a scale
0.25 Units on a scale
Standard Deviation 1.06
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 92
0.50 Units on a scale
Standard Deviation 0.71
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 93
0.50 Units on a scale
Standard Deviation 0.71
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 94
0.50 Units on a scale
Standard Deviation NA
Only 1 participant.
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Week 95
0.00 Units on a scale
Standard Deviation NA
Only 1 participant.
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Time of First Pd
-0.08 Units on a scale
Standard Deviation 1.12
-0.45 Units on a scale
Standard Deviation 0.93
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Cough: Time of Last Tx Dose
-0.15 Units on a scale
Standard Deviation 0.95
-0.29 Units on a scale
Standard Deviation 0.91
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 1
0.20 Units on a scale
Standard Deviation 0.82
0.16 Units on a scale
Standard Deviation 0.81
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 2
0.11 Units on a scale
Standard Deviation 0.76
0.15 Units on a scale
Standard Deviation 0.82
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 3
0.10 Units on a scale
Standard Deviation 0.71
0.12 Units on a scale
Standard Deviation 0.70
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 4
0.21 Units on a scale
Standard Deviation 0.84
0.17 Units on a scale
Standard Deviation 0.95
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 5
0.22 Units on a scale
Standard Deviation 0.82
0.17 Units on a scale
Standard Deviation 0.91
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 6
0.23 Units on a scale
Standard Deviation 0.82
0.16 Units on a scale
Standard Deviation 0.95
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 7
0.30 Units on a scale
Standard Deviation 0.93
0.25 Units on a scale
Standard Deviation 0.92
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 8
0.35 Units on a scale
Standard Deviation 0.87
0.24 Units on a scale
Standard Deviation 0.96
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 9
0.34 Units on a scale
Standard Deviation 0.89
0.17 Units on a scale
Standard Deviation 0.91
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 10
0.46 Units on a scale
Standard Deviation 0.93
0.16 Units on a scale
Standard Deviation 0.92
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 11
0.39 Units on a scale
Standard Deviation 1.01
0.26 Units on a scale
Standard Deviation 0.96
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 43
0.32 Units on a scale
Standard Deviation 0.89
0.22 Units on a scale
Standard Deviation 0.90
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 44
0.58 Units on a scale
Standard Deviation 0.83
0.23 Units on a scale
Standard Deviation 0.92
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 45
0.49 Units on a scale
Standard Deviation 0.96
0.21 Units on a scale
Standard Deviation 0.90
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 46
0.55 Units on a scale
Standard Deviation 1.02
0.23 Units on a scale
Standard Deviation 0.89
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 47
0.53 Units on a scale
Standard Deviation 1.09
0.14 Units on a scale
Standard Deviation 0.90
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 48
0.55 Units on a scale
Standard Deviation 0.96
0.14 Units on a scale
Standard Deviation 0.85
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 49
0.63 Units on a scale
Standard Deviation 1.04
0.16 Units on a scale
Standard Deviation 0.90
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 50
0.52 Units on a scale
Standard Deviation 0.98
0.24 Units on a scale
Standard Deviation 0.94
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 51
0.67 Units on a scale
Standard Deviation 1.04
0.30 Units on a scale
Standard Deviation 0.97
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 52
0.72 Units on a scale
Standard Deviation 1.02
0.27 Units on a scale
Standard Deviation 1.02
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 53
0.81 Units on a scale
Standard Deviation 1.06
0.22 Units on a scale
Standard Deviation 0.95
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 54
0.82 Units on a scale
Standard Deviation 1.06
0.23 Units on a scale
Standard Deviation 0.95
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 55
0.77 Units on a scale
Standard Deviation 1.17
0.16 Units on a scale
Standard Deviation 0.99
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 56
0.84 Units on a scale
Standard Deviation 1.15
0.18 Units on a scale
Standard Deviation 0.95
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 57
0.68 Units on a scale
Standard Deviation 1.16
0.11 Units on a scale
Standard Deviation 0.91
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 58
0.77 Units on a scale
Standard Deviation 1.06
0.16 Units on a scale
Standard Deviation 0.86
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 59
0.66 Units on a scale
Standard Deviation 0.90
0.07 Units on a scale
Standard Deviation 0.85
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 60
0.73 Units on a scale
Standard Deviation 0.96
0.27 Units on a scale
Standard Deviation 0.94
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 61
0.85 Units on a scale
Standard Deviation 1.04
0.23 Units on a scale
Standard Deviation 0.90
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 62
0.95 Units on a scale
Standard Deviation 1.05
0.16 Units on a scale
Standard Deviation 0.92
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 63
0.67 Units on a scale
Standard Deviation 1.01
0.27 Units on a scale
Standard Deviation 0.95
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 64
0.46 Units on a scale
Standard Deviation 0.78
0.14 Units on a scale
Standard Deviation 0.93
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 65
0.40 Units on a scale
Standard Deviation 0.66
0.12 Units on a scale
Standard Deviation 0.95
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 66
0.67 Units on a scale
Standard Deviation 0.74
0.16 Units on a scale
Standard Deviation 0.94
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 67
0.37 Units on a scale
Standard Deviation 0.76
0.26 Units on a scale
Standard Deviation 1.01
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 68
0.47 Units on a scale
Standard Deviation 0.80
0.25 Units on a scale
Standard Deviation 1.03
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 69
0.43 Units on a scale
Standard Deviation 0.80
0.16 Units on a scale
Standard Deviation 1.11
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 70
0.33 Units on a scale
Standard Deviation 0.83
0.07 Units on a scale
Standard Deviation 0.89
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 71
0.40 Units on a scale
Standard Deviation 0.91
0.13 Units on a scale
Standard Deviation 0.89
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 72
-0.05 Units on a scale
Standard Deviation 0.25
0.06 Units on a scale
Standard Deviation 0.91
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 73
0.45 Units on a scale
Standard Deviation 1.04
0.09 Units on a scale
Standard Deviation 0.99
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 74
0.50 Units on a scale
Standard Deviation 1.01
0.27 Units on a scale
Standard Deviation 1.19
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 75
0.55 Units on a scale
Standard Deviation 0.97
0.45 Units on a scale
Standard Deviation 1.31
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 76
-0.07 Units on a scale
Standard Deviation 0.12
0.02 Units on a scale
Standard Deviation 1.10
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 77
0.00 Units on a scale
Standard Deviation 0.00
0.09 Units on a scale
Standard Deviation 1.17
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 78
0.00 Units on a scale
Standard Deviation 0.00
0.03 Units on a scale
Standard Deviation 1.19
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 79
0.00 Units on a scale
Standard Deviation 0.00
0.19 Units on a scale
Standard Deviation 1.18
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 80
0.10 Units on a scale
Standard Deviation 0.14
-0.26 Units on a scale
Standard Deviation 0.80
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 81
0.10 Units on a scale
Standard Deviation 0.14
-0.17 Units on a scale
Standard Deviation 1.15
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 82
0.00 Units on a scale
Standard Deviation 0.00
0.18 Units on a scale
Standard Deviation 1.54
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 83
0.00 Units on a scale
Standard Deviation 0.00
0.45 Units on a scale
Standard Deviation 1.22
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 84
0.00 Units on a scale
Standard Deviation 0.00
0.60 Units on a scale
Standard Deviation 1.10
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 85
0.20 Units on a scale
Standard Deviation NA
Only 1 participant.
0.32 Units on a scale
Standard Deviation 1.53
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 86
0.00 Units on a scale
Standard Deviation NA
Only 1 participant.
-0.15 Units on a scale
Standard Deviation 0.34
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 87
0.20 Units on a scale
Standard Deviation NA
Only 1 participant.
-0.47 Units on a scale
Standard Deviation 0.23
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 88
0.20 Units on a scale
Standard Deviation NA
Only 1 participant.
-0.70 Units on a scale
Standard Deviation 0.20
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 89
0.20 Units on a scale
Standard Deviation NA
Only 1 participant.
-0.20 Units on a scale
Standard Deviation 0.57
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 90
0.20 Units on a scale
Standard Deviation NA
Only 1 participant.
-0.50 Units on a scale
Standard Deviation 0.14
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 91
0.00 Units on a scale
Standard Deviation NA
Only 1 participant.
-0.50 Units on a scale
Standard Deviation 0.14
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 92
-0.70 Units on a scale
Standard Deviation 0.14
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 93
-0.40 Units on a scale
Standard Deviation 0.28
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 94
-0.80 Units on a scale
Standard Deviation NA
Only 1 participant.
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 95
-1.00 Units on a scale
Standard Deviation NA
Only 1 participant.
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Time of First Pd
0.58 Units on a scale
Standard Deviation 0.99
0.40 Units on a scale
Standard Deviation 1.06
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Time of Last Tx Dose
0.47 Units on a scale
Standard Deviation 0.95
0.18 Units on a scale
Standard Deviation 0.94
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 1
0.20 Units on a scale
Standard Deviation 0.83
0.30 Units on a scale
Standard Deviation 0.88
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 2
-0.01 Units on a scale
Standard Deviation 0.88
0.21 Units on a scale
Standard Deviation 0.85
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 3
-0.05 Units on a scale
Standard Deviation 0.92
0.06 Units on a scale
Standard Deviation 0.95
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 4
0.03 Units on a scale
Standard Deviation 0.91
0.03 Units on a scale
Standard Deviation 0.93
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 5
-0.02 Units on a scale
Standard Deviation 0.93
-0.01 Units on a scale
Standard Deviation 0.88
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 6
-0.05 Units on a scale
Standard Deviation 0.88
-0.02 Units on a scale
Standard Deviation 0.92
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 7
0.07 Units on a scale
Standard Deviation 1.00
-0.04 Units on a scale
Standard Deviation 1.00
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 8
0.03 Units on a scale
Standard Deviation 0.94
-0.07 Units on a scale
Standard Deviation 1.02
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 9
0.06 Units on a scale
Standard Deviation 1.00
-0.03 Units on a scale
Standard Deviation 1.03
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 10
0.03 Units on a scale
Standard Deviation 1.02
0.02 Units on a scale
Standard Deviation 1.05
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 11
0.02 Units on a scale
Standard Deviation 0.96
0.04 Units on a scale
Standard Deviation 1.09
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 12
-0.02 Units on a scale
Standard Deviation 0.96
-0.01 Units on a scale
Standard Deviation 1.02
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 13
-0.05 Units on a scale
Standard Deviation 1.02
0.05 Units on a scale
Standard Deviation 0.97
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 14
-0.07 Units on a scale
Standard Deviation 1.12
0.06 Units on a scale
Standard Deviation 1.06
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 15
0.13 Units on a scale
Standard Deviation 1.16
0.08 Units on a scale
Standard Deviation 0.94
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 16
0.02 Units on a scale
Standard Deviation 1.08
0.08 Units on a scale
Standard Deviation 1.04
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 17
0.02 Units on a scale
Standard Deviation 1.08
0.00 Units on a scale
Standard Deviation 1.08
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 18
-0.06 Units on a scale
Standard Deviation 1.11
0.12 Units on a scale
Standard Deviation 1.07
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 19
-0.15 Units on a scale
Standard Deviation 1.12
0.02 Units on a scale
Standard Deviation 1.01
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 20
-0.02 Units on a scale
Standard Deviation 1.22
-0.01 Units on a scale
Standard Deviation 1.03
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 21
0.03 Units on a scale
Standard Deviation 1.28
0.01 Units on a scale
Standard Deviation 1.03
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 22
0.04 Units on a scale
Standard Deviation 1.21
0.02 Units on a scale
Standard Deviation 1.02
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 23
-0.08 Units on a scale
Standard Deviation 1.14
0.04 Units on a scale
Standard Deviation 0.96
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 24
-0.02 Units on a scale
Standard Deviation 1.16
0.09 Units on a scale
Standard Deviation 0.99
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 25
0.05 Units on a scale
Standard Deviation 1.24
0.14 Units on a scale
Standard Deviation 1.03
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 26
-0.05 Units on a scale
Standard Deviation 1.14
0.09 Units on a scale
Standard Deviation 1.00
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 27
0.04 Units on a scale
Standard Deviation 1.17
0.04 Units on a scale
Standard Deviation 1.01
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 28
0.24 Units on a scale
Standard Deviation 1.18
0.03 Units on a scale
Standard Deviation 0.93
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 29
0.06 Units on a scale
Standard Deviation 1.29
0.04 Units on a scale
Standard Deviation 0.95
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 30
0.01 Units on a scale
Standard Deviation 1.37
0.04 Units on a scale
Standard Deviation 0.97
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 31
0.02 Units on a scale
Standard Deviation 1.09
0.05 Units on a scale
Standard Deviation 0.88
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 32
0.21 Units on a scale
Standard Deviation 1.21
-0.01 Units on a scale
Standard Deviation 0.98
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 33
0.04 Units on a scale
Standard Deviation 1.17
0.03 Units on a scale
Standard Deviation 0.92
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 34
0.21 Units on a scale
Standard Deviation 1.27
0.11 Units on a scale
Standard Deviation 0.99
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 35
0.33 Units on a scale
Standard Deviation 1.30
0.11 Units on a scale
Standard Deviation 0.98
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 36
0.15 Units on a scale
Standard Deviation 1.07
0.17 Units on a scale
Standard Deviation 1.04
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 37
0.15 Units on a scale
Standard Deviation 1.21
0.06 Units on a scale
Standard Deviation 0.94
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 38
0.12 Units on a scale
Standard Deviation 1.16
0.04 Units on a scale
Standard Deviation 1.03
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 39
0.20 Units on a scale
Standard Deviation 1.23
0.13 Units on a scale
Standard Deviation 1.01
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 40
0.15 Units on a scale
Standard Deviation 1.31
0.04 Units on a scale
Standard Deviation 0.96
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 41
-0.05 Units on a scale
Standard Deviation 1.06
0.09 Units on a scale
Standard Deviation 1.03
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 42
-0.06 Units on a scale
Standard Deviation 1.07
0.03 Units on a scale
Standard Deviation 1.02
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 43
-0.22 Units on a scale
Standard Deviation 0.82
0.13 Units on a scale
Standard Deviation 1.02
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Chest Pain: Week 44
-0.10 Units on a scale
Standard Deviation 1.29
0.10 Units on a scale
Standard Deviation 1.04
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 12
0.38 Units on a scale
Standard Deviation 0.96
0.22 Units on a scale
Standard Deviation 0.90
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 13
0.34 Units on a scale
Standard Deviation 0.96
0.30 Units on a scale
Standard Deviation 1.02
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 14
0.44 Units on a scale
Standard Deviation 0.95
0.22 Units on a scale
Standard Deviation 0.99
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 15
0.45 Units on a scale
Standard Deviation 0.94
0.19 Units on a scale
Standard Deviation 0.95
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Dyspnoea: Week 16
0.37 Units on a scale
Standard Deviation 1.06
0.26 Units on a scale
Standard Deviation 1.02

SECONDARY outcome

Timeframe: Predose (Prd; 0 hour [h]) on D1 of Cy 2,3,4,8,16 (Cy length=21 days) and thereafter on D1 of every 8th cycle (up to approximately 25 months)

Population: PK analyses were based on PK observations from all patients who received atezolizumab, carboplatin, cisplatin or pemetrexed treatment and who provided at least one evaluable PK sample.

Minimum observed serum atezolizumab concentration (Cmin) prior to infusion at selected cycles (Arm A)

Outcome measures

Outcome measures
Measure
Arm B (Carboplatin or Cisplatin + Pemetrexed)
n=247 Participants
Participants received IV infusion of 500 mg/m\^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m\^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Minimum Observed Serum Atezolizumab Concentration (Cmin)
Cy2D1
69.8 μg/mL
Standard Deviation 32.3
Minimum Observed Serum Atezolizumab Concentration (Cmin)
Cy3D1
115 μg/mL
Standard Deviation 51.5
Minimum Observed Serum Atezolizumab Concentration (Cmin)
Cy4D1
151 μg/mL
Standard Deviation 69.9
Minimum Observed Serum Atezolizumab Concentration (Cmin)
Cy8D1
221 μg/mL
Standard Deviation 101
Minimum Observed Serum Atezolizumab Concentration (Cmin)
Cy16D1
234 μg/mL
Standard Deviation 86.7
Minimum Observed Serum Atezolizumab Concentration (Cmin)
Cy24D1
257 μg/mL
Standard Deviation 95.1
Minimum Observed Serum Atezolizumab Concentration (Cmin)
Treatment Discontinuation Visit
129 μg/mL
Standard Deviation 93.1
Minimum Observed Serum Atezolizumab Concentration (Cmin)
Day 120 Post Last Dose
13.4 μg/mL
Standard Deviation 19.4

SECONDARY outcome

Timeframe: Day 1 of Cycle 1 (Cycle length=21 days)

Population: PK analyses were based on PK observations from all patients who received atezolizumab, carboplatin, cisplatin or pemetrexed treatment and who provided at least one evaluable PK sample.

Maximum observed serum atezolizumab concentration (Cmax) after infusion (Arm A)

Outcome measures

Outcome measures
Measure
Arm B (Carboplatin or Cisplatin + Pemetrexed)
n=273 Participants
Participants received IV infusion of 500 mg/m\^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m\^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Maximum Observed Serum Atezolizumab Concentration (Cmax)
403 μg/mL
Standard Deviation 118

SECONDARY outcome

Timeframe: Prd (0 h), 5-10 minutes (mins) before end of carboplatin infusion (infusion duration=1-2 h), 1 h post-infusion on D1 of Cy1,3 (Cy length=21 days)

Population: PK analyses were based on PK observations from all patients who received atezolizumab, carboplatin, cisplatin or pemetrexed treatment and who provided at least one evaluable PK sample.

Outcome measures

Outcome measures
Measure
Arm B (Carboplatin or Cisplatin + Pemetrexed)
n=27 Participants
Participants received IV infusion of 500 mg/m\^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m\^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Plasma Concentrations for Carboplatin in Arm A(Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Cy1D1 Predose
NA ng/mL
Standard Deviation NA
Predose of Cycle 1 Day 1 administration of Carboplatin.
Plasma Concentrations for Carboplatin in Arm A(Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Cy1D1 Before End of Infusion
14900 ng/mL
Standard Deviation 4260
Plasma Concentrations for Carboplatin in Arm A(Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Cy1D1 Post Infusion
12800 ng/mL
Standard Deviation 4470
Plasma Concentrations for Carboplatin in Arm A(Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Cy3D1 Predose
220 ng/mL
Standard Deviation 83.8
Plasma Concentrations for Carboplatin in Arm A(Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Cy3D1 Before End of Infusion
17900 ng/mL
Standard Deviation 4390
Plasma Concentrations for Carboplatin in Arm A(Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Cy3D1 Post Infusion
13900 ng/mL
Standard Deviation 4080

SECONDARY outcome

Timeframe: Prd (0 h), 5-10 mins before end of cisplatin infusion (infusion duration=30-60 mins), 1 h post-infusion on D1 of Cy1,3 (Cy length=21 days)

Population: PK analyses were based on PK observations from all patients who received atezolizumab, carboplatin, cisplatin or pemetrexed treatment and who provided at least one evaluable PK sample.

Outcome measures

Outcome measures
Measure
Arm B (Carboplatin or Cisplatin + Pemetrexed)
n=10 Participants
Participants received IV infusion of 500 mg/m\^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m\^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Plasma Concentrations for Cisplatin in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Cy1D1 Predose
NA ng/mL
Standard Deviation NA
Predose of Cycle 1 Day 1 administration of Cisplatin.
Plasma Concentrations for Cisplatin in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Cy1D1 Before End of Infusion
3630 ng/mL
Standard Deviation 589
Plasma Concentrations for Cisplatin in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Cy1D1 Post Infusion
2400 ng/mL
Standard Deviation 360
Plasma Concentrations for Cisplatin in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Cy3D1 Predose
290 ng/mL
Standard Deviation 86.1
Plasma Concentrations for Cisplatin in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Cy3D1 Before End of Infusion
3020 ng/mL
Standard Deviation 968
Plasma Concentrations for Cisplatin in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Cy3D1 Post Infusion
2740 ng/mL
Standard Deviation 543

SECONDARY outcome

Timeframe: Prd (0 h), 5-10 mins before end of pemetrexed infusion (infusion duration=10 mins), 1 h post-infusion on D1 of Cy1,3 (Cy length=21 days)

Population: PK analyses were based on PK observations from all patients who received atezolizumab, carboplatin, cisplatin or pemetrexed treatment and who provided at least one evaluable PK sample.

Outcome measures

Outcome measures
Measure
Arm B (Carboplatin or Cisplatin + Pemetrexed)
n=36 Participants
Participants received IV infusion of 500 mg/m\^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m\^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Plasma Concentrations for Pemetrexed in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Cy1D1 Predose
NA ng/mL
Standard Deviation NA
Predose of Cycle 1 Day 1 administration of Pemetrexed.
Plasma Concentrations for Pemetrexed in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Cy1D1 Before End of Infusion
86500 ng/mL
Standard Deviation 41600
Plasma Concentrations for Pemetrexed in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Cy1D1 Post Infusion
43600 ng/mL
Standard Deviation 15800
Plasma Concentrations for Pemetrexed in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Cy3D1 Predose
1.83 ng/mL
Standard Deviation 0.681
Plasma Concentrations for Pemetrexed in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Cy3D1 Before End of Inufsion
79400 ng/mL
Standard Deviation 44400
Plasma Concentrations for Pemetrexed in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Cy3D1 Post Infusion
50100 ng/mL
Standard Deviation 26100

SECONDARY outcome

Timeframe: Prd (0 h) on D1 of Cy1,2,3,4,8,16 (Cy length=21 days) and thereafter on D1 of every 8th cycle, at treatment discontinuation & then every 30 days (up to 120 days) after last dose of atezolizumab (up to app 25 months)

Population: The ADA evaluable population was defined as patients with a non-missing baseline ADA sample and \>=1 non-missing post-baseline ADA sample.

Baseline prevalence and post-baseline incidence of anti-drug antibodies (ADA) to Atezolizumab in the Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)

Outcome measures

Outcome measures
Measure
Arm B (Carboplatin or Cisplatin + Pemetrexed)
n=291 Participants
Participants received IV infusion of 500 mg/m\^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m\^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) of Atezolizumab
Baseline Evaluable Participants
1.8 Percentage of Participants
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) of Atezolizumab
Post-Baseline Evaluable Participants
35.4 Percentage of Participants

Adverse Events

Arm B (Carboplatin or Cisplatin + Pemetrexed)

Serious events: 91 serious events
Other events: 255 other events
Deaths: 189 deaths

Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed

Serious events: 149 serious events
Other events: 275 other events
Deaths: 190 deaths

Serious adverse events

Serious adverse events
Measure
Arm B (Carboplatin or Cisplatin + Pemetrexed)
n=274 participants at risk
Participants received IV infusion of 500 mg/m\^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who do not experience disease progression during the induction phase will begin maintenance therapy. Participants will receive IV infusion of 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
n=291 participants at risk
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m\^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Blood and lymphatic system disorders
ANAEMIA
2.6%
7/274 • Number of events 10 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
3.8%
11/291 • Number of events 14 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Blood and lymphatic system disorders
FEBRILE BONE MARROW APLASIA
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
1.8%
5/274 • Number of events 5 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
4.1%
12/291 • Number of events 12 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Blood and lymphatic system disorders
LEUKOPENIA
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.69%
2/291 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Blood and lymphatic system disorders
NEUTROPENIA
1.1%
3/274 • Number of events 3 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
1.0%
3/291 • Number of events 3 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Blood and lymphatic system disorders
PANCYTOPENIA
1.5%
4/274 • Number of events 6 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
1.4%
4/291 • Number of events 4 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Blood and lymphatic system disorders
THROMBOCYTOPENIA
1.5%
4/274 • Number of events 4 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
3.8%
11/291 • Number of events 15 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
0.73%
2/274 • Number of events 3 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Cardiac disorders
ATRIAL FIBRILLATION
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Cardiac disorders
CARDIAC FAILURE
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Cardiac disorders
CARDIAC FAILURE ACUTE
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Cardiac disorders
MYOCARDITIS
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Cardiac disorders
STRESS CARDIOMYOPATHY
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Cardiac disorders
TACHYCARDIA
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Endocrine disorders
HYPOTHYROIDISM
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Eye disorders
CATARACT
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.69%
2/291 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Gastrointestinal disorders
ABDOMINAL PAIN
0.73%
2/274 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
1.4%
4/291 • Number of events 4 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Gastrointestinal disorders
AUTOIMMUNE COLITIS
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Gastrointestinal disorders
COLITIS
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.69%
2/291 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Gastrointestinal disorders
CONSTIPATION
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Gastrointestinal disorders
DIARRHOEA
1.1%
3/274 • Number of events 3 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
3.1%
9/291 • Number of events 9 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Gastrointestinal disorders
DIVERTICULUM INTESTINAL HAEMORRHAGIC
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Gastrointestinal disorders
ENTEROCOLITIS
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Gastrointestinal disorders
GASTRIC PERFORATION
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Gastrointestinal disorders
GASTROINTESTINAL DISORDER
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Gastrointestinal disorders
INGUINAL HERNIA
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Gastrointestinal disorders
NAUSEA
0.73%
2/274 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.69%
2/291 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Gastrointestinal disorders
OESOPHAGITIS
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 3 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Gastrointestinal disorders
PANCREATITIS
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Gastrointestinal disorders
PROCTITIS ULCERATIVE
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Gastrointestinal disorders
SMALL INTESTINAL PERFORATION
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Gastrointestinal disorders
STOMATITIS
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Gastrointestinal disorders
VOMITING
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
2.1%
6/291 • Number of events 6 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
General disorders
ASTHENIA
0.73%
2/274 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
1.7%
5/291 • Number of events 5 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
General disorders
CHEST PAIN
0.73%
2/274 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
General disorders
DEATH
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.69%
2/291 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
General disorders
DISEASE SUSCEPTIBILITY
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
General disorders
FATIGUE
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.69%
2/291 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
General disorders
GAIT DISTURBANCE
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
1.0%
3/291 • Number of events 4 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
General disorders
INFLAMMATION
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
General disorders
MALAISE
0.73%
2/274 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
General disorders
MUCOSAL INFLAMMATION
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
General disorders
NON-CARDIAC CHEST PAIN
0.73%
2/274 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
General disorders
PAIN
0.73%
2/274 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
General disorders
PYREXIA
0.73%
2/274 • Number of events 3 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
4.1%
12/291 • Number of events 12 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Hepatobiliary disorders
AUTOIMMUNE HEPATITIS
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Hepatobiliary disorders
CHOLANGITIS
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Hepatobiliary disorders
CHOLELITHIASIS
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Hepatobiliary disorders
DRUG-INDUCED LIVER INJURY
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.69%
2/291 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Hepatobiliary disorders
HEPATITIS
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Hepatobiliary disorders
HEPATITIS ACUTE
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Hepatobiliary disorders
HEPATOTOXICITY
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.69%
2/291 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Immune system disorders
CYTOKINE RELEASE SYNDROME
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Immune system disorders
HYPERSENSITIVITY
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.69%
2/291 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
BACTERAEMIA
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
BRONCHITIS
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.69%
2/291 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
BRONCHOPULMONARY ASPERGILLOSIS
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
CAMPYLOBACTER GASTROENTERITIS
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
CELLULITIS
0.73%
2/274 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
1.0%
3/291 • Number of events 3 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
DIVERTICULITIS
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
ENCEPHALITIS
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
ERYSIPELAS
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
ESCHERICHIA URINARY TRACT INFECTION
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
H3N2 INFLUENZA
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
INFECTIOUS PLEURAL EFFUSION
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
INFLUENZA
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
1.0%
3/291 • Number of events 3 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
0.73%
2/274 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
MENINGITIS
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
NEUTROPENIC SEPSIS
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
OESOPHAGEAL CANDIDIASIS
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
PERIPHERAL NERVE INFECTION
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
PHARYNGITIS
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
PNEUMONIA
5.8%
16/274 • Number of events 17 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
5.8%
17/291 • Number of events 18 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
PULMONARY SEPSIS
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.69%
2/291 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
PYELONEPHRITIS
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
RESPIRATORY TRACT INFECTION
0.73%
2/274 • Number of events 3 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
2.1%
6/291 • Number of events 9 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
SEPSIS
0.73%
2/274 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
1.4%
4/291 • Number of events 4 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
SOFT TISSUE INFECTION
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
TRACHEITIS
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
URINARY TRACT INFECTION
0.73%
2/274 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
2.1%
6/291 • Number of events 6 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
UROSEPSIS
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Injury, poisoning and procedural complications
FEMUR FRACTURE
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Injury, poisoning and procedural complications
INTENTIONAL OVERDOSE
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL FRACTURE
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Injury, poisoning and procedural complications
SKIN INJURY
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Injury, poisoning and procedural complications
STAB WOUND
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Injury, poisoning and procedural complications
TOXICITY TO VARIOUS AGENTS
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Investigations
ALANINE AMINOTRANSFERASE INCREASED
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
1.0%
3/291 • Number of events 3 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Investigations
BLOOD CREATININE INCREASED
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
1.0%
3/291 • Number of events 3 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Investigations
CREATININE RENAL CLEARANCE DECREASED
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Investigations
NEUTROPHIL COUNT DECREASED
1.1%
3/274 • Number of events 5 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Investigations
PLATELET COUNT DECREASED
1.1%
3/274 • Number of events 3 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Investigations
WEIGHT DECREASED
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Investigations
WHITE BLOOD CELL COUNT DECREASED
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Metabolism and nutrition disorders
DECREASED APPETITE
0.73%
2/274 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Metabolism and nutrition disorders
DEHYDRATION
1.5%
4/274 • Number of events 4 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.69%
2/291 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Metabolism and nutrition disorders
DIABETES MELLITUS INADEQUATE CONTROL
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Metabolism and nutrition disorders
GOUT
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Metabolism and nutrition disorders
HYPERCALCAEMIA
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Metabolism and nutrition disorders
HYPERGLYCAEMIA
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
1.0%
3/291 • Number of events 4 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Metabolism and nutrition disorders
HYPERKALAEMIA
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Metabolism and nutrition disorders
HYPOKALAEMIA
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Metabolism and nutrition disorders
HYPONATRAEMIA
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.69%
2/291 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Musculoskeletal and connective tissue disorders
BACK PAIN
0.73%
2/274 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Musculoskeletal and connective tissue disorders
BONE PAIN
0.73%
2/274 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Musculoskeletal and connective tissue disorders
FRACTURE PAIN
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Musculoskeletal and connective tissue disorders
MYALGIA
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Musculoskeletal and connective tissue disorders
NECK PAIN
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA GASTRIC
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER PAIN
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HISTIOCYTIC NECROTISING LYMPHADENITIS
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO CENTRAL NERVOUS SYSTEM
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER RECURRENT
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR EMBOLISM
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Nervous system disorders
APHASIA
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Nervous system disorders
ATAXIA
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Nervous system disorders
BRAIN OEDEMA
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Nervous system disorders
CAROTID ARTERY OCCLUSION
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Nervous system disorders
CAROTID ARTERY STENOSIS
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Nervous system disorders
CEREBRAL HAEMORRHAGE
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Nervous system disorders
CEREBRAL INFARCTION
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Nervous system disorders
CEREBROVASCULAR ACCIDENT
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
1.4%
4/291 • Number of events 4 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Nervous system disorders
HEADACHE
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.69%
2/291 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Nervous system disorders
LETHARGY
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Nervous system disorders
SEIZURE
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Nervous system disorders
SYNCOPE
0.73%
2/274 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Product Issues
DEVICE MALFUNCTION
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Psychiatric disorders
ANXIETY
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Psychiatric disorders
CATATONIA
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Psychiatric disorders
COMPLETED SUICIDE
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Renal and urinary disorders
ACUTE KIDNEY INJURY
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
1.0%
3/291 • Number of events 3 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Renal and urinary disorders
CHRONIC KIDNEY DISEASE
0.36%
1/274 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Renal and urinary disorders
GLYCOSURIA
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Renal and urinary disorders
NEPHRITIS ALLERGIC
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.69%
2/291 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Renal and urinary disorders
RENAL FAILURE
0.73%
2/274 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Renal and urinary disorders
RENAL IMPAIRMENT
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Renal and urinary disorders
TUBULOINTERSTITIAL NEPHRITIS
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.69%
2/291 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
BRONCHIAL HYPERREACTIVITY
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.73%
2/274 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.69%
2/291 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
1.1%
3/274 • Number of events 3 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.69%
2/291 • Number of events 4 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.69%
2/291 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
HYPERVENTILATION
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
ORGANISING PNEUMONIA
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
PHARYNGEAL INFLAMMATION
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
1.1%
3/274 • Number of events 4 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
1.5%
4/274 • Number of events 4 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
3.1%
9/291 • Number of events 9 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
1.5%
4/274 • Number of events 4 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
1.4%
4/291 • Number of events 4 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
PULMONARY HAEMORRHAGE
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Skin and subcutaneous tissue disorders
DERMATITIS
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.69%
2/291 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Skin and subcutaneous tissue disorders
RASH
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.69%
2/291 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Vascular disorders
AORTIC EMBOLUS
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Vascular disorders
DEEP VEIN THROMBOSIS
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Vascular disorders
EMBOLISM
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Vascular disorders
HYPERTENSION
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Vascular disorders
HYPOTENSION
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Vascular disorders
PERIPHERAL ARTERY THROMBOSIS
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Vascular disorders
PERIPHERAL ISCHAEMIA
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Vascular disorders
THROMBOPHLEBITIS
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Vascular disorders
VASCULITIS
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Blood and lymphatic system disorders
MYELOSUPPRESSION
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Hepatobiliary disorders
BILIARY OBSTRUCTION
0.36%
1/274 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Hepatobiliary disorders
CONGESTIVE HEPATOPATHY
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
GASTROENTERITIS
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
GASTROENTERITIS CLOSTRIDIAL
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
LARYNGOPHARYNGITIS
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
PNEUMONIA ASPIRATION
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.69%
2/291 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
VASCULAR ACCESS SITE CELLULITIS
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Injury, poisoning and procedural complications
FALL
0.00%
0/274 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.34%
1/291 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Nervous system disorders
CHANGE IN SEIZURE PRESENTATION
0.36%
1/274 • Number of events 1 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
0.00%
0/291 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.

Other adverse events

Other adverse events
Measure
Arm B (Carboplatin or Cisplatin + Pemetrexed)
n=274 participants at risk
Participants received IV infusion of 500 mg/m\^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who do not experience disease progression during the induction phase will begin maintenance therapy. Participants will receive IV infusion of 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
n=291 participants at risk
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m\^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Blood and lymphatic system disorders
ANAEMIA
41.2%
113/274 • Number of events 142 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
44.3%
129/291 • Number of events 186 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Blood and lymphatic system disorders
NEUTROPENIA
13.9%
38/274 • Number of events 65 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
16.5%
48/291 • Number of events 95 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Blood and lymphatic system disorders
THROMBOCYTOPENIA
8.4%
23/274 • Number of events 37 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
13.4%
39/291 • Number of events 60 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Endocrine disorders
HYPOTHYROIDISM
0.73%
2/274 • Number of events 2 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
6.2%
18/291 • Number of events 19 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Eye disorders
LACRIMATION INCREASED
6.6%
18/274 • Number of events 21 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
5.5%
16/291 • Number of events 16 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
1.8%
5/274 • Number of events 7 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
5.2%
15/291 • Number of events 20 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Gastrointestinal disorders
CONSTIPATION
28.8%
79/274 • Number of events 96 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
31.6%
92/291 • Number of events 104 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Gastrointestinal disorders
DIARRHOEA
17.2%
47/274 • Number of events 56 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
20.6%
60/291 • Number of events 88 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Gastrointestinal disorders
DYSPEPSIA
3.3%
9/274 • Number of events 10 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
5.5%
16/291 • Number of events 18 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Gastrointestinal disorders
NAUSEA
41.6%
114/274 • Number of events 206 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
38.5%
112/291 • Number of events 266 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Gastrointestinal disorders
STOMATITIS
8.4%
23/274 • Number of events 26 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
12.0%
35/291 • Number of events 45 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Gastrointestinal disorders
VOMITING
17.9%
49/274 • Number of events 64 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
19.9%
58/291 • Number of events 81 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
General disorders
ASTHENIA
19.7%
54/274 • Number of events 81 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
27.1%
79/291 • Number of events 118 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
General disorders
CHEST PAIN
6.6%
18/274 • Number of events 18 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
7.6%
22/291 • Number of events 25 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
General disorders
FATIGUE
24.8%
68/274 • Number of events 98 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
24.4%
71/291 • Number of events 116 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
General disorders
MALAISE
6.2%
17/274 • Number of events 23 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
4.8%
14/291 • Number of events 23 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
General disorders
MUCOSAL INFLAMMATION
6.9%
19/274 • Number of events 28 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
7.9%
23/291 • Number of events 24 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
General disorders
OEDEMA PERIPHERAL
12.0%
33/274 • Number of events 38 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
15.8%
46/291 • Number of events 66 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
General disorders
PYREXIA
13.5%
37/274 • Number of events 50 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
20.3%
59/291 • Number of events 89 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
CONJUNCTIVITIS
5.5%
15/274 • Number of events 18 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
6.2%
18/291 • Number of events 23 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
3.6%
10/274 • Number of events 13 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
5.5%
16/291 • Number of events 22 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Investigations
ALANINE AMINOTRANSFERASE INCREASED
8.4%
23/274 • Number of events 29 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
17.9%
52/291 • Number of events 74 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
9.9%
27/274 • Number of events 35 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
17.5%
51/291 • Number of events 78 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Investigations
BLOOD CREATININE INCREASED
7.3%
20/274 • Number of events 26 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
11.7%
34/291 • Number of events 43 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Investigations
NEUTROPHIL COUNT DECREASED
17.5%
48/274 • Number of events 108 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
15.5%
45/291 • Number of events 116 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Investigations
PLATELET COUNT DECREASED
13.9%
38/274 • Number of events 69 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
13.1%
38/291 • Number of events 63 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Investigations
WEIGHT DECREASED
5.8%
16/274 • Number of events 17 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
8.9%
26/291 • Number of events 26 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Investigations
WHITE BLOOD CELL COUNT DECREASED
10.6%
29/274 • Number of events 67 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
6.9%
20/291 • Number of events 58 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Metabolism and nutrition disorders
DECREASED APPETITE
23.4%
64/274 • Number of events 84 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
26.8%
78/291 • Number of events 101 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Metabolism and nutrition disorders
HYPERGLYCAEMIA
6.2%
17/274 • Number of events 20 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
5.2%
15/291 • Number of events 17 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Metabolism and nutrition disorders
HYPOKALAEMIA
1.5%
4/274 • Number of events 4 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
7.2%
21/291 • Number of events 29 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
5.1%
14/274 • Number of events 19 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
6.5%
19/291 • Number of events 31 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Musculoskeletal and connective tissue disorders
ARTHRALGIA
9.5%
26/274 • Number of events 29 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
15.8%
46/291 • Number of events 61 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Musculoskeletal and connective tissue disorders
BACK PAIN
9.1%
25/274 • Number of events 28 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
13.7%
40/291 • Number of events 51 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
4.7%
13/274 • Number of events 13 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
7.9%
23/291 • Number of events 23 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Nervous system disorders
DIZZINESS
8.8%
24/274 • Number of events 27 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
6.5%
19/291 • Number of events 23 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Nervous system disorders
DYSGEUSIA
6.9%
19/274 • Number of events 19 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
9.6%
28/291 • Number of events 33 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Nervous system disorders
HEADACHE
8.8%
24/274 • Number of events 26 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
12.0%
35/291 • Number of events 39 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Nervous system disorders
PARAESTHESIA
5.1%
14/274 • Number of events 16 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
4.1%
12/291 • Number of events 13 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Psychiatric disorders
INSOMNIA
6.6%
18/274 • Number of events 18 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
9.6%
28/291 • Number of events 35 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
COUGH
10.9%
30/274 • Number of events 36 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
14.8%
43/291 • Number of events 58 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
14.6%
40/274 • Number of events 42 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
15.1%
44/291 • Number of events 50 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
6.9%
19/274 • Number of events 22 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
4.5%
13/291 • Number of events 16 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
HICCUPS
6.2%
17/274 • Number of events 24 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
5.5%
16/291 • Number of events 35 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Skin and subcutaneous tissue disorders
DRY SKIN
2.6%
7/274 • Number of events 7 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
6.9%
20/291 • Number of events 23 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Skin and subcutaneous tissue disorders
PRURITUS
5.8%
16/274 • Number of events 17 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
10.0%
29/291 • Number of events 37 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Skin and subcutaneous tissue disorders
RASH
7.7%
21/274 • Number of events 23 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
14.1%
41/291 • Number of events 54 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Vascular disorders
HYPERTENSION
2.6%
7/274 • Number of events 9 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
5.8%
17/291 • Number of events 31 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
NASOPHARYNGITIS
2.9%
8/274 • Number of events 10 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
5.2%
15/291 • Number of events 20 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Infections and infestations
PNEUMONIA
4.0%
11/274 • Number of events 12 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
5.5%
16/291 • Number of events 20 • From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

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