Trial Outcomes & Findings for Efficacy Comparison of Dostarlimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) (NCT NCT04581824)

NCT ID: NCT04581824

Last Updated: 2025-08-08

Results Overview

ORR was defined as the percentage of participants who had a confirmed complete response (CR) or confirmed partial response (PR) as their best overall response (BOR) recorded from the date of randomization until disease progression or initiation of new anti-cancer therapy, whichever is earlier based on blinded independent central review (BICR) evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeter in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters (e.g., percent change from baseline).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

243 participants

Primary outcome timeframe

Up to approximately 20 months

Results posted on

2025-08-08

Participant Flow

Participant milestones

Participant milestones
Measure
Dostarlimab + Chemotherapy
Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Pembrolizumab + Chemotherapy
Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Overall Study
STARTED
121
122
Overall Study
COMPLETED
81
92
Overall Study
NOT COMPLETED
40
30

Reasons for withdrawal

Reasons for withdrawal
Measure
Dostarlimab + Chemotherapy
Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Pembrolizumab + Chemotherapy
Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Overall Study
Lost to Follow-up
1
0
Overall Study
Withdrawal by Subject
2
7
Overall Study
Study terminated by sponsor
37
23

Baseline Characteristics

Efficacy Comparison of Dostarlimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Dostarlimab + Chemotherapy
n=121 Participants
Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Pembrolizumab + Chemotherapy
n=122 Participants
Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Total
n=243 Participants
Total of all reporting groups
Age, Continuous
63.4 YEARS
STANDARD_DEVIATION 9.43 • n=5 Participants
65.4 YEARS
STANDARD_DEVIATION 8.51 • n=7 Participants
64.4 YEARS
STANDARD_DEVIATION 9.02 • n=5 Participants
Sex: Female, Male
Female
36 Participants
n=5 Participants
45 Participants
n=7 Participants
81 Participants
n=5 Participants
Sex: Female, Male
Male
85 Participants
n=5 Participants
77 Participants
n=7 Participants
162 Participants
n=5 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
23 Participants
n=5 Participants
21 Participants
n=7 Participants
44 Participants
n=5 Participants
Race/Ethnicity, Customized
Black or African American
1 Participants
n=5 Participants
3 Participants
n=7 Participants
4 Participants
n=5 Participants
Race/Ethnicity, Customized
White
87 Participants
n=5 Participants
84 Participants
n=7 Participants
171 Participants
n=5 Participants
Race/Ethnicity, Customized
Multiple
3 Participants
n=5 Participants
3 Participants
n=7 Participants
6 Participants
n=5 Participants
Race/Ethnicity, Customized
Not Reported
2 Participants
n=5 Participants
5 Participants
n=7 Participants
7 Participants
n=5 Participants
Race/Ethnicity, Customized
Unknown
4 Participants
n=5 Participants
6 Participants
n=7 Participants
10 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 20 months

Population: Intent-to-treat (ITT) population included all participants who were randomized.

ORR was defined as the percentage of participants who had a confirmed complete response (CR) or confirmed partial response (PR) as their best overall response (BOR) recorded from the date of randomization until disease progression or initiation of new anti-cancer therapy, whichever is earlier based on blinded independent central review (BICR) evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeter in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters (e.g., percent change from baseline).

Outcome measures

Outcome measures
Measure
Dostarlimab + Chemotherapy
n=121 Participants
Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Pembrolizumab + Chemotherapy
n=122 Participants
Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Objective Response Rate (ORR)
46 Percentage of Participants
Interval 37.2 to 55.6
37 Percentage of Participants
Interval 28.3 to 46.1

SECONDARY outcome

Timeframe: Up to approximately 46 months

Population: Intent-to-treat (ITT) population

OS was defined as the time from the date of randomization to the date of death by any cause.

Outcome measures

Outcome measures
Measure
Dostarlimab + Chemotherapy
n=121 Participants
Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Pembrolizumab + Chemotherapy
n=122 Participants
Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Overall Survival (OS)
20.2 Months
Interval 14.5 to 27.3
15.9 Months
Interval 11.6 to 19.3

SECONDARY outcome

Timeframe: Up to approximately 46 months

Population: Intent-to-treat (ITT) population

PFS was defined as the time from the date of randomization to the date of disease progression (PD) or death by any cause, whichever occurs first. PFS was evaluated using Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1 based on Investigator assessment. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start).

Outcome measures

Outcome measures
Measure
Dostarlimab + Chemotherapy
n=121 Participants
Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Pembrolizumab + Chemotherapy
n=122 Participants
Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Progression-free Survival (PFS)
8.8 Months
Interval 6.9 to 11.0
6.8 Months
Interval 4.9 to 7.1

SECONDARY outcome

Timeframe: Up to 46 months

Population: Safety population included all participants who received at least 1 dose of study treatment.

AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. Number of participants with TEAEs, TEAEs leading to death, and TEAEs leading to treatment discontinuation are presented. AEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).

Outcome measures

Outcome measures
Measure
Dostarlimab + Chemotherapy
n=121 Participants
Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Pembrolizumab + Chemotherapy
n=122 Participants
Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Number of Participants With Treatment-emergent Adverse Event (TEAEs), TEAEs Leading to Death and TEAEs Leading to Treatment Discontinuation
TEAEs
119 Participants
119 Participants
Number of Participants With Treatment-emergent Adverse Event (TEAEs), TEAEs Leading to Death and TEAEs Leading to Treatment Discontinuation
TEAEs leading to death
17 Participants
12 Participants
Number of Participants With Treatment-emergent Adverse Event (TEAEs), TEAEs Leading to Death and TEAEs Leading to Treatment Discontinuation
TEAEs leading to treatment discontinuation
35 Participants
46 Participants

SECONDARY outcome

Timeframe: Up to 46 months

Population: Safety population

The irAEs are events which are severe or fatal and can occur in participants treated with monoclonal antibodies directed against immune checkpoints, including pembrolizumab and dostarlimab. While irAEs (eg, diarrhea/colitis, pneumonitis, nephritis, hypophysitis, adrenalitis, thyroiditis, severe skin reactions, uveitis, myocarditis, and hepatotoxicity) usually occur during treatment, symptoms can also manifest after discontinuation of treatment. AEs were coded using the MedDRA dictionary.

Outcome measures

Outcome measures
Measure
Dostarlimab + Chemotherapy
n=121 Participants
Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Pembrolizumab + Chemotherapy
n=122 Participants
Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Number of Participants With Treatment Emergent Immune-related Adverse Event (irAE)
38 Participants
47 Participants

SECONDARY outcome

Timeframe: Up to approximately 46 months

Population: Safety population

An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is an important medical event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the above outcomes. SAEs are subset of AEs. AEs were coded using the MedDRA dictionary.

Outcome measures

Outcome measures
Measure
Dostarlimab + Chemotherapy
n=121 Participants
Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Pembrolizumab + Chemotherapy
n=122 Participants
Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Number of Participants With Serious AEs
51 Participants
61 Participants

SECONDARY outcome

Timeframe: Up to approximately 46 months

Population: Safety population. Only those participants with data available at specified categories have been analyzed.

Normal ranges were 30 to 110 units per liter (U/L) (Amylase); 4. 5 to 5. 6 milligram/deciliters (mg/dL) (Calcium); 96 to 100 milliequivalents (mEq)/ L (Chloride); 2. 5 to 4.5 mg/dL (Phosphate); 6 to 8.3 grams/L (protein); 6 to 24 millimoles/L (Urea) and 7 to 20 mg/dL (Urea nitrogen). Participants were counted in worst case category that their value changes to low, normal or no change \[NC\] or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g. High to High) or whose value became normal, were recorded in "To Normal or No Change" category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%.

Outcome measures

Outcome measures
Measure
Dostarlimab + Chemotherapy
n=117 Participants
Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Pembrolizumab + Chemotherapy
n=115 Participants
Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Amylase, To Low
8 Participants
11 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Amylase, To Normal or No Change
76 Participants
76 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Amylase, To High
34 Participants
30 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Calcium, To Low
42 Participants
39 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Calcium, To Normal or No Change
60 Participants
65 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Calcium, To High
25 Participants
16 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Chloride, To Low
34 Participants
26 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Chloride, To Normal or No Change
65 Participants
69 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Chloride, To High
22 Participants
25 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Phosphate, To Low
32 Participants
22 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Phosphate, To Normal or No Change
64 Participants
70 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Phosphate, To High
26 Participants
28 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Protein, To Low
52 Participants
54 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Protein, To Normal or No Change
55 Participants
56 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Protein, To High
12 Participants
6 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Urea, To Low
7 Participants
11 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Urea, To Normal or No Change
43 Participants
45 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Urea, To High
41 Participants
37 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Urea Nitrogen, To Low
5 Participants
6 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Urea Nitrogen, To Normal or No Change
26 Participants
17 Participants
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Urea Nitrogen, To High
20 Participants
13 Participants

SECONDARY outcome

Timeframe: Up to approximately 46 months

Population: Safety population. Only those participants with data available at specified categories have been analyzed.

Normal ranges were 0.01 to 0.3\*10\^9 cells/L (basophils); 41 to 50 percentage of red blood cells (RBC) in blood (hematocrit); 80-100 femtoliters (fl) (erythrocytes \[referred as Ery\] mean corpuscular volume (EMCV)); 2 to 8 percentage of WBC (monocytes); and Women: 4.2 to 5.4 million RBC/ microliter (mcL) of blood and Men: 4.7 to 6.1 million RBC/ mcL (erythrocytes). Participants were counted in worst case category that their value changes to low, normal or no change \[NC\] or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g. High to High) or whose value became normal, were recorded in "To Normal or No Change" category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%.

Outcome measures

Outcome measures
Measure
Dostarlimab + Chemotherapy
n=118 Participants
Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Pembrolizumab + Chemotherapy
n=115 Participants
Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Basophils, To Low
12 Participants
9 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Basophils, To Normal or No Change
72 Participants
75 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Basophils, To High
19 Participants
19 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Hematocrit, To Low
73 Participants
64 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Hematocrit, To Normal or No Change
43 Participants
50 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Hematocrit, To High
3 Participants
1 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
EMCV, To Low
6 Participants
11 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
EMCV, To Normal or No Change
59 Participants
54 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
EMCV, To High
57 Participants
54 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Monocytes, To Low
23 Participants
21 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Monocytes, To Normal or No Change
41 Participants
42 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Monocytes, To High
46 Participants
43 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Erythrocytes, To Low
73 Participants
79 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Erythrocytes, To Normal or No Change
44 Participants
34 Participants
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Erythrocytes, To High
2 Participants
6 Participants

SECONDARY outcome

Timeframe: Up to approximately 46 months

Population: Safety population. Only those participants with data available at specified categories have been analyzed

Urine samples were collected to assess urine Bilirubin, glucose, ketones, Leukocyte Esterase, Nitrite, occult blood and Protein using dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as No Change/Decreased, Increase to TRACE, Increase to +, Increase to ++, Increase to +++ and Increase to ++++. Baseline (Day 1) was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

Outcome measures

Outcome measures
Measure
Dostarlimab + Chemotherapy
n=93 Participants
Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Pembrolizumab + Chemotherapy
n=71 Participants
Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Bilirubin, No Change/Decreased
86 Participants
66 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Bilirubin, Increase to TRACE
0 Participants
0 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Bilirubin, Increase to +
4 Participants
3 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Bilirubin, Increase to ++
0 Participants
0 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Bilirubin, Increase to +++
0 Participants
0 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Bilirubin, Increase to ++++
0 Participants
0 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Glucose, No Change/Decreased
79 Participants
57 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Glucose, Increase to TRACE
2 Participants
1 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Glucose, Increase to +
8 Participants
8 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Glucose, Increase to ++
1 Participants
2 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Glucose, Increase to +++
1 Participants
2 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Glucose, Increase to ++++
2 Participants
1 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Ketones, No Change/Decreased
81 Participants
58 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Ketones, Increase to TRACE
4 Participants
3 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Ketones, Increase to +
8 Participants
7 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Ketones, Increase to ++
0 Participants
2 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Ketones, Increase to +++
0 Participants
1 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Ketones, Increase to ++++
0 Participants
0 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Leukocyte Esterase, No Change/Decreased
75 Participants
55 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Leukocyte Esterase, Increase to TRACE
1 Participants
2 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Leukocyte Esterase, Increase to +
11 Participants
10 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Leukocyte Esterase, Increase to ++
2 Participants
0 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Leukocyte Esterase, Increase to +++
1 Participants
3 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Leukocyte Esterase, Increase to ++++
1 Participants
0 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Nitrite, No Change/Decreased
90 Participants
70 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Nitrite, Increase to TRACE
0 Participants
0 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Nitrite, Increase to +
3 Participants
1 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Nitrite, Increase to ++
0 Participants
0 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Nitrite, Increase to +++
0 Participants
0 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Nitrite, Increase to ++++
0 Participants
0 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Occult Blood, No Change/Decreased
77 Participants
57 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Occult Blood, Increase to TRACE
6 Participants
3 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Occult Blood, Increase to +
6 Participants
8 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Occult Blood, Increase to ++
3 Participants
3 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Occult Blood, Increase to +++
0 Participants
0 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Occult Blood, Increase to ++++
0 Participants
0 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Protein, No Change/Decreased
71 Participants
53 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Protein, Increase to TRACE
7 Participants
3 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Protein, Increase to +
14 Participants
10 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Protein, Increase to ++
0 Participants
3 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Protein, Increase to +++
1 Participants
1 Participants
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Protein, Increase to ++++
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Up to approximately 46 months

Population: Safety population. Only those participants with data available at specified categories have been analyzed

Blood samples were collected for the assessment Free Triiodothyronine (T3) and Free Thyroxine (T4).

Outcome measures

Outcome measures
Measure
Dostarlimab + Chemotherapy
n=90 Participants
Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Pembrolizumab + Chemotherapy
n=106 Participants
Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Triiodothyronine, Free, Baseline
4.48026 Picomoles per liter(pmol/L)
Standard Deviation 1.638746
4.48540 Picomoles per liter(pmol/L)
Standard Deviation 1.066597
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Triiodothyronine, Free, CFB to Cycle 2 Day 1
-0.12423 Picomoles per liter(pmol/L)
Standard Deviation 2.071042
-0.24330 Picomoles per liter(pmol/L)
Standard Deviation 1.026993
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Triiodothyronine, Free, CFB to Cycle 4 Day 1
-0.00187 Picomoles per liter(pmol/L)
Standard Deviation 2.206972
-0.11796 Picomoles per liter(pmol/L)
Standard Deviation 1.413190
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Triiodothyronine, Free, CFB to Cycle 6 Day 1
-0.15030 Picomoles per liter(pmol/L)
Standard Deviation 2.128584
-0.37705 Picomoles per liter(pmol/L)
Standard Deviation 1.117516
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Triiodothyronine, Free, CFB to Cycle 8 Day 1
0.11483 Picomoles per liter(pmol/L)
Standard Deviation 2.738875
-0.43073 Picomoles per liter(pmol/L)
Standard Deviation 1.123017
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Triiodothyronine, Free, CFB to Cycle 10 Day 1
-0.25993 Picomoles per liter(pmol/L)
Standard Deviation 2.187046
-0.23819 Picomoles per liter(pmol/L)
Standard Deviation 1.273369
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Triiodothyronine, Free, CFB to Cycle 12 Day 1
-0.04347 Picomoles per liter(pmol/L)
Standard Deviation 2.817465
5.82171 Picomoles per liter(pmol/L)
Standard Deviation 34.328615
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Triiodothyronine, Free, CFB to Cycle 14 Day 1
-0.61895 Picomoles per liter(pmol/L)
Standard Deviation 2.558169
-0.33501 Picomoles per liter(pmol/L)
Standard Deviation 1.597219
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Triiodothyronine, Free, CFB to Cycle 16 Day 1
-0.44645 Picomoles per liter(pmol/L)
Standard Deviation 2.274173
-0.36614 Picomoles per liter(pmol/L)
Standard Deviation 1.108135
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Triiodothyronine, Free, CFB to Cycle 18 Day 1
-0.37234 Picomoles per liter(pmol/L)
Standard Deviation 2.414983
-0.12607 Picomoles per liter(pmol/L)
Standard Deviation 1.337185
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Triiodothyronine, Free, CFB to Cycle 20 Day 1
-0.37506 Picomoles per liter(pmol/L)
Standard Deviation 2.495642
-0.26936 Picomoles per liter(pmol/L)
Standard Deviation 1.237097
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Triiodothyronine, Free, CFB to Cycle 22 Day 1
-0.36400 Picomoles per liter(pmol/L)
Standard Deviation 2.759103
-0.17980 Picomoles per liter(pmol/L)
Standard Deviation 1.018812
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Triiodothyronine, Free, CFB to Cycle 24 Day 1
-0.69144 Picomoles per liter(pmol/L)
Standard Deviation 2.662922
-0.18380 Picomoles per liter(pmol/L)
Standard Deviation 0.736262
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Triiodothyronine, Free, CFB to Cycle 26 Day 1
0.01392 Picomoles per liter(pmol/L)
Standard Deviation 1.331466
-0.39401 Picomoles per liter(pmol/L)
Standard Deviation 0.669173
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Triiodothyronine, Free, CFB to Cycle 28 Day 1
-0.05502 Picomoles per liter(pmol/L)
Standard Deviation 1.094085
-0.28233 Picomoles per liter(pmol/L)
Standard Deviation 0.880805
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Triiodothyronine, Free, CFB to Cycle 30 Day 1
0.11929 Picomoles per liter(pmol/L)
Standard Deviation 1.151771
-0.19119 Picomoles per liter(pmol/L)
Standard Deviation 0.911551
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Triiodothyronine, Free, CFB to Cycle 32 Day 1
0.54114 Picomoles per liter(pmol/L)
Standard Deviation 1.043916
0.03556 Picomoles per liter(pmol/L)
Standard Deviation 1.067239
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Triiodothyronine, Free, CFB to Cycle 34 Day 1
0.62534 Picomoles per liter(pmol/L)
Standard Deviation 0.957105
-0.32236 Picomoles per liter(pmol/L)
Standard Deviation 0.774334
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Triiodothyronine, Free, CFB to End of Treatment
-0.64275 Picomoles per liter(pmol/L)
Standard Deviation 2.184114
-0.40528 Picomoles per liter(pmol/L)
Standard Deviation 1.086922
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Thyroxine, Free, Baseline
16.33405 Picomoles per liter(pmol/L)
Standard Deviation 4.294246
15.93013 Picomoles per liter(pmol/L)
Standard Deviation 3.436512
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Thyroxine, Free, CFB to Cycle 2 Day 1
-0.35227 Picomoles per liter(pmol/L)
Standard Deviation 4.257866
0.21349 Picomoles per liter(pmol/L)
Standard Deviation 3.541952
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Thyroxine, Free, CFB to Cycle 4 Day 1
0.04265 Picomoles per liter(pmol/L)
Standard Deviation 6.245167
0.08969 Picomoles per liter(pmol/L)
Standard Deviation 4.015042
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Thyroxine, Free, CFB to Cycle 6 Day 1
-0.10229 Picomoles per liter(pmol/L)
Standard Deviation 5.418010
-0.58695 Picomoles per liter(pmol/L)
Standard Deviation 3.404576
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Thyroxine, Free, CFB to Cycle 8 Day 1
-1.02504 Picomoles per liter(pmol/L)
Standard Deviation 6.168755
0.27944 Picomoles per liter(pmol/L)
Standard Deviation 3.877876
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Thyroxine, Free, CFB to Cycle 10 Day 1
-1.15108 Picomoles per liter(pmol/L)
Standard Deviation 5.586383
0.08349 Picomoles per liter(pmol/L)
Standard Deviation 3.613602
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Thyroxine, Free, CFB to Cycle 12 Day 1
-0.16670 Picomoles per liter(pmol/L)
Standard Deviation 6.081753
4.71828 Picomoles per liter(pmol/L)
Standard Deviation 27.489015
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Thyroxine, Free, CFB to Cycle 14 Day 1
0.32703 Picomoles per liter(pmol/L)
Standard Deviation 6.114475
-0.45213 Picomoles per liter(pmol/L)
Standard Deviation 4.196576
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Thyroxine, Free, CFB to Cycle 16 Day 1
-0.45337 Picomoles per liter(pmol/L)
Standard Deviation 4.840440
0.24537 Picomoles per liter(pmol/L)
Standard Deviation 3.472618
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Thyroxine, Free, CFB to Cycle 18 Day 1
0.07645 Picomoles per liter(pmol/L)
Standard Deviation 5.524789
0.47690 Picomoles per liter(pmol/L)
Standard Deviation 1.984139
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Thyroxine, Free, CFB to Cycle 20 Day 1
-0.41084 Picomoles per liter(pmol/L)
Standard Deviation 5.013270
0.37830 Picomoles per liter(pmol/L)
Standard Deviation 3.413511
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Thyroxine, Free, CFB to Cycle 22 Day 1
-0.65956 Picomoles per liter(pmol/L)
Standard Deviation 5.562802
0.45462 Picomoles per liter(pmol/L)
Standard Deviation 2.841910
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Thyroxine, Free, CFB to Cycle 24 Day 1
-0.71092 Picomoles per liter(pmol/L)
Standard Deviation 6.314352
0.31032 Picomoles per liter(pmol/L)
Standard Deviation 2.653193
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Thyroxine, Free, CFB to Cycle 26 Day 1
-0.89968 Picomoles per liter(pmol/L)
Standard Deviation 5.246300
0.23139 Picomoles per liter(pmol/L)
Standard Deviation 3.443957
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Thyroxine, Free, CFB to Cycle 28 Day 1
-0.89658 Picomoles per liter(pmol/L)
Standard Deviation 5.489130
1.10907 Picomoles per liter(pmol/L)
Standard Deviation 2.849631
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Thyroxine, Free, CFB to Cycle 30 Day 1
-1.46126 Picomoles per liter(pmol/L)
Standard Deviation 4.811596
-0.21286 Picomoles per liter(pmol/L)
Standard Deviation 3.203649
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Thyroxine, Free, CFB to Cycle 32 Day 1
-1.81377 Picomoles per liter(pmol/L)
Standard Deviation 5.474197
0.13236 Picomoles per liter(pmol/L)
Standard Deviation 3.519557
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Thyroxine, Free, CFB to Cycle 34 Day 1
-1.52641 Picomoles per liter(pmol/L)
Standard Deviation 6.379163
0.45041 Picomoles per liter(pmol/L)
Standard Deviation 2.435328
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Thyroxine, Free, CFB to End of Treatment
0.26660 Picomoles per liter(pmol/L)
Standard Deviation 3.882315
0.46964 Picomoles per liter(pmol/L)
Standard Deviation 3.310829

SECONDARY outcome

Timeframe: Up to approximately 46 months

Population: Safety population. Only those participants with data available at specified categories have been analyzed

Blood samples were collected for the assessment of Thyroid Function Thyrotropin (TSH).

Outcome measures

Outcome measures
Measure
Dostarlimab + Chemotherapy
n=116 Participants
Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Pembrolizumab + Chemotherapy
n=120 Participants
Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Change From Baseline in Thyroid Function: Thyrotropin (TSH)
Baseline
1.853 Milli-international Units/ Liter
Standard Deviation 1.8354
1.904 Milli-international Units/ Liter
Standard Deviation 1.7421
Change From Baseline in Thyroid Function: Thyrotropin (TSH)
CFB to Cycle 2 Day 1
0.225 Milli-international Units/ Liter
Standard Deviation 3.7642
-0.497 Milli-international Units/ Liter
Standard Deviation 1.7405
Change From Baseline in Thyroid Function: Thyrotropin (TSH)
CFB to Cycle 4 Day 1
1.285 Milli-international Units/ Liter
Standard Deviation 9.4283
-0.622 Milli-international Units/ Liter
Standard Deviation 1.7892
Change From Baseline in Thyroid Function: Thyrotropin (TSH)
CFB to Cycle 6 Day 1
1.123 Milli-international Units/ Liter
Standard Deviation 8.4596
2.006 Milli-international Units/ Liter
Standard Deviation 21.0213
Change From Baseline in Thyroid Function: Thyrotropin (TSH)
CFB to Cycle 8 Day 1
2.454 Milli-international Units/ Liter
Standard Deviation 9.7235
2.648 Milli-international Units/ Liter
Standard Deviation 22.9952
Change From Baseline in Thyroid Function: Thyrotropin (TSH)
CFB to Cycle 10 Day 1
3.233 Milli-international Units/ Liter
Standard Deviation 12.1571
1.986 Milli-international Units/ Liter
Standard Deviation 12.8377
Change From Baseline in Thyroid Function: Thyrotropin (TSH)
CFB to Cycle 12 Day 1
2.448 Milli-international Units/ Liter
Standard Deviation 9.8590
1.138 Milli-international Units/ Liter
Standard Deviation 10.9780
Change From Baseline in Thyroid Function: Thyrotropin (TSH)
CFB to Cycle 14 Day 1
1.282 Milli-international Units/ Liter
Standard Deviation 4.2566
1.734 Milli-international Units/ Liter
Standard Deviation 9.0539
Change From Baseline in Thyroid Function: Thyrotropin (TSH)
CFB to Cycle 16 Day 1
1.551 Milli-international Units/ Liter
Standard Deviation 4.7982
2.056 Milli-international Units/ Liter
Standard Deviation 13.4532
Change From Baseline in Thyroid Function: Thyrotropin (TSH)
CFB to Cycle 18 Day 1
1.190 Milli-international Units/ Liter
Standard Deviation 4.1837
-0.406 Milli-international Units/ Liter
Standard Deviation 1.6364
Change From Baseline in Thyroid Function: Thyrotropin (TSH)
CFB to Cycle 20 Day 1
1.685 Milli-international Units/ Liter
Standard Deviation 5.3517
1.825 Milli-international Units/ Liter
Standard Deviation 11.8029
Change From Baseline in Thyroid Function: Thyrotropin (TSH)
CFB to Cycle 22 Day 1
1.428 Milli-international Units/ Liter
Standard Deviation 5.9512
1.794 Milli-international Units/ Liter
Standard Deviation 10.5658
Change From Baseline in Thyroid Function: Thyrotropin (TSH)
CFB to Cycle 24 Day 1
0.993 Milli-international Units/ Liter
Standard Deviation 3.0372
2.161 Milli-international Units/ Liter
Standard Deviation 10.7015
Change From Baseline in Thyroid Function: Thyrotropin (TSH)
CFB to Cycle 26 Day 1
1.029 Milli-international Units/ Liter
Standard Deviation 4.3080
2.050 Milli-international Units/ Liter
Standard Deviation 11.8067
Change From Baseline in Thyroid Function: Thyrotropin (TSH)
CFB to Cycle 28 Day 1
1.204 Milli-international Units/ Liter
Standard Deviation 3.4902
1.760 Milli-international Units/ Liter
Standard Deviation 9.6622
Change From Baseline in Thyroid Function: Thyrotropin (TSH)
CFB to Cycle 30 Day 1
1.615 Milli-international Units/ Liter
Standard Deviation 5.4966
3.468 Milli-international Units/ Liter
Standard Deviation 15.7231
Change From Baseline in Thyroid Function: Thyrotropin (TSH)
CFB to Cycle 32 Day 1
1.824 Milli-international Units/ Liter
Standard Deviation 4.9423
0.365 Milli-international Units/ Liter
Standard Deviation 0.8151
Change From Baseline in Thyroid Function: Thyrotropin (TSH)
CFB to Cycle 34 Day 1
1.081 Milli-international Units/ Liter
Standard Deviation 2.4504
-0.189 Milli-international Units/ Liter
Standard Deviation 1.5062
Change From Baseline in Thyroid Function: Thyrotropin (TSH)
CFB to End of Treatment
2.210 Milli-international Units/ Liter
Standard Deviation 8.3867
1.303 Milli-international Units/ Liter
Standard Deviation 9.3590

SECONDARY outcome

Timeframe: Up to approximately 46 months

Population: Safety population. Only those participants with data available at specified categories have been analyzed

Blood samples were collected for the assessment of Triiodothyronine (T3) and Thyroxine (T4).

Outcome measures

Outcome measures
Measure
Dostarlimab + Chemotherapy
n=27 Participants
Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Pembrolizumab + Chemotherapy
n=22 Participants
Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4)
Thyroxine, CFB to Cycle 26 Day 1
32.22436 Nanomoles per liter (nmol/L)
Standard Deviation 62.122105
35.71425 Nanomoles per liter (nmol/L)
Standard Deviation 12.285627
Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4)
Thyroxine, CFB to Cycle 28 Day 1
21.13316 Nanomoles per liter (nmol/L)
Standard Deviation 46.351292
20.55189 Nanomoles per liter (nmol/L)
Standard Deviation 17.985775
Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4)
Triiodothyronine, Baseline
1.68399 Nanomoles per liter (nmol/L)
Standard Deviation 0.308404
1.48287 Nanomoles per liter (nmol/L)
Standard Deviation 0.526037
Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4)
Triiodothyronine, CFB to Cycle 2 Day 1
0.06903 Nanomoles per liter (nmol/L)
Standard Deviation 0.172873
-0.58292 Nanomoles per liter (nmol/L)
Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4)
Triiodothyronine, CFB to Cycle 4 Day 1
-0.41878 Nanomoles per liter (nmol/L)
Standard Deviation 0.353613
Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4)
Triiodothyronine, CFB to Cycle 6 Day 1
-0.21476 Nanomoles per liter (nmol/L)
Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4)
Thyroxine, Baseline
72.72912 Nanomoles per liter (nmol/L)
Standard Deviation 46.845564
85.29069 Nanomoles per liter (nmol/L)
Standard Deviation 38.027652
Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4)
Thyroxine, CFB to Cycle 2 Day 1
16.06393 Nanomoles per liter (nmol/L)
Standard Deviation 38.489073
-3.12689 Nanomoles per liter (nmol/L)
Standard Deviation 11.544100
Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4)
Thyroxine, CFB to Cycle 4 Day 1
10.16002 Nanomoles per liter (nmol/L)
Standard Deviation 47.746764
12.22592 Nanomoles per liter (nmol/L)
Standard Deviation 30.578995
Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4)
Thyroxine, CFB to Cycle 6 Day 1
9.83083 Nanomoles per liter (nmol/L)
Standard Deviation 30.658114
-2.45916 Nanomoles per liter (nmol/L)
Standard Deviation 27.497527
Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4)
Thyroxine, CFB to Cycle 8 Day 1
21.85010 Nanomoles per liter (nmol/L)
Standard Deviation 44.242770
-0.06812 Nanomoles per liter (nmol/L)
Standard Deviation 24.146111
Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4)
Thyroxine, CFB to Cycle 10 Day 1
32.19186 Nanomoles per liter (nmol/L)
Standard Deviation 41.441071
-0.03002 Nanomoles per liter (nmol/L)
Standard Deviation 16.413851
Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4)
Thyroxine, CFB to Cycle 12 Day 1
23.45510 Nanomoles per liter (nmol/L)
Standard Deviation 36.165686
-0.82919 Nanomoles per liter (nmol/L)
Standard Deviation 9.539787
Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4)
Thyroxine, CFB to Cycle 14 Day 1
14.79794 Nanomoles per liter (nmol/L)
Standard Deviation 35.614508
0.64908 Nanomoles per liter (nmol/L)
Standard Deviation 12.623292
Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4)
Thyroxine, CFB to Cycle 16 Day 1
21.23230 Nanomoles per liter (nmol/L)
Standard Deviation 38.220665
7.86174 Nanomoles per liter (nmol/L)
Standard Deviation 18.910608
Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4)
Thyroxine, CFB to Cycle 18 Day 1
18.35801 Nanomoles per liter (nmol/L)
Standard Deviation 31.436316
7.37470 Nanomoles per liter (nmol/L)
Standard Deviation 8.635752
Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4)
Thyroxine, CFB to Cycle 20 Day 1
26.94600 Nanomoles per liter (nmol/L)
Standard Deviation 47.915257
16.06215 Nanomoles per liter (nmol/L)
Standard Deviation 18.656008
Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4)
Thyroxine, CFB to Cycle 22 Day 1
22.73866 Nanomoles per liter (nmol/L)
Standard Deviation 34.202890
18.57057 Nanomoles per liter (nmol/L)
Standard Deviation 22.383758
Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4)
Thyroxine, CFB to Cycle 24 Day 1
24.31027 Nanomoles per liter (nmol/L)
Standard Deviation 45.963345
23.08569 Nanomoles per liter (nmol/L)
Standard Deviation 20.160509
Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4)
Thyroxine, CFB to Cycle 30 Day 1
19.12904 Nanomoles per liter (nmol/L)
Standard Deviation 53.351526
13.09008 Nanomoles per liter (nmol/L)
Standard Deviation 11.862148
Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4)
Thyroxine, CFB to Cycle 32 Day 1
19.99271 Nanomoles per liter (nmol/L)
Standard Deviation 58.500079
16.73184 Nanomoles per liter (nmol/L)
Standard Deviation 23.660023
Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4)
Thyroxine, CFB to Cycle 34 Day 1
-4.97280 Nanomoles per liter (nmol/L)
Standard Deviation 8.622499
0.01300 Nanomoles per liter (nmol/L)
Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4)
Thyroxine, CFB to End of Treatment
11.06954 Nanomoles per liter (nmol/L)
Standard Deviation 35.792455
4.67311 Nanomoles per liter (nmol/L)
Standard Deviation 29.791225

SECONDARY outcome

Timeframe: Up to approximately 46 months

Population: Safety population. Only those participants with data available at specified categories have been analyzed.

DBP and SBP were measured in a semi-supine position after 5 minutes rest. Grades were derived based on numeric criteria as defined in Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Systolic Blood Pressure (SBP): Grade 0 (\<120 Millimetre of mercury (mmHg)), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (\>=160 mmHg). Diastolic Blood Pressure (DBP): Grade 0 (\<80 mmHg), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (\>=100 mmHg). An increase is defined as an increase in the CTCAE grade relative to the Baseline grade. Only those participants with grade increase have been presented. Participants with missing Baseline values were assumed to have a Baseline value of G0.

Outcome measures

Outcome measures
Measure
Dostarlimab + Chemotherapy
n=117 Participants
Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Pembrolizumab + Chemotherapy
n=115 Participants
Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Number of Participants With Worst-case Grade Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Increase to Grade 1
36 Participants
27 Participants
Number of Participants With Worst-case Grade Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Increase to Grade 2
35 Participants
25 Participants
Number of Participants With Worst-case Grade Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Increase to Grade 3
6 Participants
7 Participants
Number of Participants With Worst-case Grade Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Increase to Grade 1
24 Participants
18 Participants
Number of Participants With Worst-case Grade Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Increase to Grade 2
34 Participants
24 Participants
Number of Participants With Worst-case Grade Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Increase to Grade 3
8 Participants
11 Participants

SECONDARY outcome

Timeframe: Up to approximately 46 months

Population: Safety population. Only those participants with data available at specified categories have been analyzed.

Normal range of Pulse Rate was 60 to 100 beats/min. Participants were counted in worst case category that their value changes to low, to within \[w/in\] Range or No Change \[NC\] or high, unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g. High to High) or whose value became normal, were recorded in "To Normal or No Change" category.

Outcome measures

Outcome measures
Measure
Dostarlimab + Chemotherapy
n=117 Participants
Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Pembrolizumab + Chemotherapy
n=115 Participants
Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Number of Participants With Worst Case Pulse Rate Results Post-Baseline Relative to Baseline Based on Potential Clinical Importance (PCI)
To Low
5 Participants
3 Participants
Number of Participants With Worst Case Pulse Rate Results Post-Baseline Relative to Baseline Based on Potential Clinical Importance (PCI)
To w/in Range or No Change
105 Participants
103 Participants
Number of Participants With Worst Case Pulse Rate Results Post-Baseline Relative to Baseline Based on Potential Clinical Importance (PCI)
To High
7 Participants
9 Participants

SECONDARY outcome

Timeframe: Up to approximately 46 months

Population: Safety population.

Performance status was assessed using the ECOG scale (Grade 0-5). Grades: 0: Fully active, able to carry on all pre-disease performance without restriction. 1: Restricted in physically strenuous activity but ambulatory, able to carry out work of light nature. 2: Ambulatory, capable of self-care, unable to carry out work activities. Up and about more than 50% waking hours. 3: Capable of limited self-care, confined to bed/chair more than 50% waking hours. 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed/chair. 5: Dead.

Outcome measures

Outcome measures
Measure
Dostarlimab + Chemotherapy
n=118 Participants
Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Pembrolizumab + Chemotherapy
n=115 Participants
Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Number of Participants With Worst-Case Post-Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
0
15 Participants
20 Participants
Number of Participants With Worst-Case Post-Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
1
70 Participants
57 Participants
Number of Participants With Worst-Case Post-Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
2
24 Participants
20 Participants
Number of Participants With Worst-Case Post-Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
3
4 Participants
14 Participants
Number of Participants With Worst-Case Post-Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
4-5
5 Participants
4 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Cycle 1 Day 1, and end of treatment (Up to approximately 46 months)

Population: Safety population. Only those participants with data available at specified categories have been analyzed

Participants were in a supine or semi recumbent position (about 30 degrees of elevation) and rested for approximately 2 minutes before ECGs were recorded. Single 12-lead ECG was recorded using an ECG machine. PR, QRS, QT, QTcF, and RR intervals were recorded

Outcome measures

Outcome measures
Measure
Dostarlimab + Chemotherapy
n=121 Participants
Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Pembrolizumab + Chemotherapy
n=122 Participants
Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Mean Change From Baseline in Electrocardiogram (ECG) Parameters
QTcF Interval, CFB to End of Treatment
1.4 Millisecond (msec)
Standard Deviation 65.82
-10.0 Millisecond (msec)
Standard Deviation 60.00
Mean Change From Baseline in Electrocardiogram (ECG) Parameters
QTcF Interval, CFB to Cycle 1 Day 1
-12.3 Millisecond (msec)
Standard Deviation 48.19
-4.7 Millisecond (msec)
Standard Deviation 4.16
Mean Change From Baseline in Electrocardiogram (ECG) Parameters
RR Interval, Baseline
741.3 Millisecond (msec)
Standard Deviation 205.25
766.5 Millisecond (msec)
Standard Deviation 195.43
Mean Change From Baseline in Electrocardiogram (ECG) Parameters
PR Interval, Baseline
157.3 Millisecond (msec)
Standard Deviation 26.87
152.4 Millisecond (msec)
Standard Deviation 25.54
Mean Change From Baseline in Electrocardiogram (ECG) Parameters
PR Interval, CFB to Cycle 1 Day 1
-6.0 Millisecond (msec)
Standard Deviation 1.41
8.7 Millisecond (msec)
Standard Deviation 16.17
Mean Change From Baseline in Electrocardiogram (ECG) Parameters
PR Interval, CFB to End of Treatment
-5.3 Millisecond (msec)
Standard Deviation 23.35
0.2 Millisecond (msec)
Standard Deviation 17.49
Mean Change From Baseline in Electrocardiogram (ECG) Parameters
QRS Duration, Baseline
87.9 Millisecond (msec)
Standard Deviation 14.85
89.0 Millisecond (msec)
Standard Deviation 14.91
Mean Change From Baseline in Electrocardiogram (ECG) Parameters
QRS Duration, CFB to Cycle 1 Day 1
10.0 Millisecond (msec)
Standard Deviation 13.08
6.0 Millisecond (msec)
Standard Deviation 14.14
Mean Change From Baseline in Electrocardiogram (ECG) Parameters
QRS Duration, CFB to End of Treatment
3.3 Millisecond (msec)
Standard Deviation 17.14
-1.1 Millisecond (msec)
Standard Deviation 13.47
Mean Change From Baseline in Electrocardiogram (ECG) Parameters
QT Interval, Baseline
370.4 Millisecond (msec)
Standard Deviation 35.29
374.3 Millisecond (msec)
Standard Deviation 38.05
Mean Change From Baseline in Electrocardiogram (ECG) Parameters
QT Interval, CFB to Cycle 1 Day 1
-19.5 Millisecond (msec)
Standard Deviation 48.23
-27.3 Millisecond (msec)
Standard Deviation 57.98
Mean Change From Baseline in Electrocardiogram (ECG) Parameters
QT Interval, CFB to End of Treatment
-1.7 Millisecond (msec)
Standard Deviation 36.57
-4.1 Millisecond (msec)
Standard Deviation 38.07
Mean Change From Baseline in Electrocardiogram (ECG) Parameters
QTcB Interval, Baseline
459.3 Millisecond (msec)
Standard Deviation 190.83
440.4 Millisecond (msec)
Standard Deviation 121.20
Mean Change From Baseline in Electrocardiogram (ECG) Parameters
QTcB Interval, CFB to Cycle 1 Day 1
-309.0 Millisecond (msec)
Standard Deviation 559.52
-31.7 Millisecond (msec)
Standard Deviation 49.81
Mean Change From Baseline in Electrocardiogram (ECG) Parameters
QTcB Interval, CFB to End of Treatment
-12.2 Millisecond (msec)
Standard Deviation 176.21
-3.1 Millisecond (msec)
Standard Deviation 30.81
Mean Change From Baseline in Electrocardiogram (ECG) Parameters
QTcF Interval, Baseline
406.6 Millisecond (msec)
Standard Deviation 50.60
412.9 Millisecond (msec)
Standard Deviation 48.99
Mean Change From Baseline in Electrocardiogram (ECG) Parameters
RR Interval, CFB to Cycle 1 Day 1
81.3 Millisecond (msec)
Standard Deviation 256.20
-10.7 Millisecond (msec)
Standard Deviation 81.05
Mean Change From Baseline in Electrocardiogram (ECG) Parameters
RR Interval, CFB to End of Treatment
-3.3 Millisecond (msec)
Standard Deviation 183.71
2.5 Millisecond (msec)
Standard Deviation 193.04

SECONDARY outcome

Timeframe: Baseline (Day 1), Cycle 1 Day 1, and end of treatment (Up to approximately 46 months)

Population: Safety population. Only those participants with data available at specified categories have been analyzed

Participants were in a supine or semi recumbent position (about 30 degrees of elevation) and rested for approximately 2 minutes before ECGs were recorded. Single 12-lead ECG was recorded using an ECG machine. Mean Heart rate were recorded.

Outcome measures

Outcome measures
Measure
Dostarlimab + Chemotherapy
n=121 Participants
Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Pembrolizumab + Chemotherapy
n=122 Participants
Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Mean Change From Baseline in ECG Mean Heart Rate
Baseline
79.8 beats/min
Standard Deviation 15.17
80.0 beats/min
Standard Deviation 16.14
Mean Change From Baseline in ECG Mean Heart Rate
CFB to Cycle 1 Day 1
0.0 beats/min
Standard Deviation 13.04
3.3 beats/min
Standard Deviation 13.65
Mean Change From Baseline in ECG Mean Heart Rate
CFB to End of Treatment
1.5 beats/min
Standard Deviation 14.71
0.6 beats/min
Standard Deviation 17.95

SECONDARY outcome

Timeframe: Up to approximately 46 months

Population: Safety population

Number of participants received concomitant medications were summarized.

Outcome measures

Outcome measures
Measure
Dostarlimab + Chemotherapy
n=121 Participants
Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Pembrolizumab + Chemotherapy
n=122 Participants
Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Number Participant Who Used Concomitant Medications
121 Participants
122 Participants

Adverse Events

Dostarlimab + Chemotherapy

Serious events: 51 serious events
Other events: 117 other events
Deaths: 80 deaths

Pembrolizumab + Chemotherapy

Serious events: 61 serious events
Other events: 114 other events
Deaths: 91 deaths

Serious adverse events

Serious adverse events
Measure
Dostarlimab + Chemotherapy
n=121 participants at risk
Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Pembrolizumab + Chemotherapy
n=122 participants at risk
Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Blood and lymphatic system disorders
Anaemia
7.4%
9/121 • Number of events 11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
4.9%
6/122 • Number of events 7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders
Febrile neutropenia
3.3%
4/121 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
3.3%
4/122 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders
Myelosuppression
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
2.5%
3/122 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders
Pancytopenia
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
1.6%
2/122 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders
Thrombocytopenia
2.5%
3/121 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
2.5%
3/122 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Cardiac disorders
Acute myocardial infarction
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Cardiac disorders
Cardiac arrest
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
1.6%
2/122 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Cardiac disorders
Cardiac failure
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Cardiac disorders
Pericardial effusion
0.83%
1/121 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
1.6%
2/122 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Abdominal pain
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Colitis
0.83%
1/121 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
1.6%
2/122 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Constipation
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
1.6%
2/122 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Diarrhoea
1.7%
2/121 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
1.6%
2/122 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Dysphagia
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Enteritis
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Intestinal obstruction
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Nausea
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Oesophagitis
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Pancreatitis acute
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Vomiting
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
General disorders
Asthenia
2.5%
3/121 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
General disorders
Chest pain
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
General disorders
Disease progression
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
General disorders
General physical health deterioration
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
General disorders
Pain
1.7%
2/121 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
General disorders
Pyrexia
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
3.3%
4/122 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
General disorders
Sudden cardiac death
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
General disorders
Sudden death
2.5%
3/121 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Hepatobiliary disorders
Hepatitis
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Immune system disorders
Hypersensitivity
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Infections and infestations
COVID-19
3.3%
4/121 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
2.5%
3/122 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Infections and infestations
COVID-19 pneumonia
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Infections and infestations
Cellulitis
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Infections and infestations
Clostridium difficile infection
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Infections and infestations
Gastroenteritis salmonella
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Infections and infestations
Pneumocystis jirovecii pneumonia
0.83%
1/121 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Infections and infestations
Pneumonia
3.3%
4/121 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
12.3%
15/122 • Number of events 15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Infections and infestations
Pulmonary sepsis
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Infections and infestations
Respiratory tract infection
2.5%
3/121 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Infections and infestations
Sepsis
1.7%
2/121 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
1.6%
2/122 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Infections and infestations
Septic shock
1.7%
2/121 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
1.6%
2/122 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Infections and infestations
Strongyloidiasis
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Infections and infestations
Urinary tract infection
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Infections and infestations
Urosepsis
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Infections and infestations
Viral infection
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications
Fracture
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications
Gastroenteritis radiation
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications
Lumbar vertebral fracture
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications
Wound complication
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Investigations
Alanine aminotransferase increased
1.7%
2/121 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Investigations
Aspartate aminotransferase increased
0.83%
1/121 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Investigations
Blood alkaline phosphatase increased
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Investigations
Gamma-glutamyltransferase increased
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Investigations
Platelet count decreased
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
1.6%
2/122 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders
Dehydration
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders
Diabetic ketoacidosis
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
1.6%
2/122 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders
Hypomagnesaemia
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders
Bone pain
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal neoplasm
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Nervous system disorders
Cerebral ischaemia
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Nervous system disorders
Cerebrovascular accident
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Nervous system disorders
Dysarthria
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Nervous system disorders
Haemorrhage intracranial
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Nervous system disorders
Immune-mediated encephalitis
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Nervous system disorders
Ischaemic stroke
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Nervous system disorders
Monoparesis
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Nervous system disorders
Seizure
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Nervous system disorders
Transient aphasia
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Psychiatric disorders
Confusional state
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Renal and urinary disorders
Acute kidney injury
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Renal and urinary disorders
Chronic kidney disease
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Renal and urinary disorders
Pollakiuria
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Renal and urinary disorders
Renal failure
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Aspiration
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
1.7%
2/121 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
2.5%
3/122 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
4.1%
5/121 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
3.3%
4/122 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
2.5%
3/122 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
3.3%
4/121 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
2.5%
3/121 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
4.1%
5/122 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
1.7%
2/121 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
1.6%
2/122 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
2.5%
3/122 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders
Angioedema
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders
Rash
0.83%
1/121 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.00%
0/122 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Vascular disorders
Embolism
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Vascular disorders
Peripheral artery stenosis
0.00%
0/121 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
0.82%
1/122 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.

Other adverse events

Other adverse events
Measure
Dostarlimab + Chemotherapy
n=121 participants at risk
Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Pembrolizumab + Chemotherapy
n=122 participants at risk
Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
Blood and lymphatic system disorders
Anaemia
52.1%
63/121 • Number of events 194 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
48.4%
59/122 • Number of events 156 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders
Neutropenia
18.2%
22/121 • Number of events 42 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
20.5%
25/122 • Number of events 45 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders
Thrombocytopenia
11.6%
14/121 • Number of events 30 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
8.2%
10/122 • Number of events 15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Endocrine disorders
Hyperthyroidism
6.6%
8/121 • Number of events 11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
1.6%
2/122 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Endocrine disorders
Hypothyroidism
9.1%
11/121 • Number of events 13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
5.7%
7/122 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Constipation
19.8%
24/121 • Number of events 37 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
21.3%
26/122 • Number of events 31 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Diarrhoea
17.4%
21/121 • Number of events 31 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
13.9%
17/122 • Number of events 20 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Nausea
25.6%
31/121 • Number of events 105 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
26.2%
32/122 • Number of events 66 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Stomatitis
6.6%
8/121 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
4.1%
5/122 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Vomiting
20.7%
25/121 • Number of events 38 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
13.1%
16/122 • Number of events 21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
General disorders
Asthenia
33.9%
41/121 • Number of events 99 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
34.4%
42/122 • Number of events 90 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
General disorders
Chest pain
2.5%
3/121 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
6.6%
8/122 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
General disorders
Fatigue
12.4%
15/121 • Number of events 37 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
13.1%
16/122 • Number of events 22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
General disorders
Mucosal inflammation
5.8%
7/121 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
5.7%
7/122 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
General disorders
Oedema peripheral
11.6%
14/121 • Number of events 20 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
9.0%
11/122 • Number of events 22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
General disorders
Pain
5.8%
7/121 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
2.5%
3/122 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
General disorders
Pyrexia
11.6%
14/121 • Number of events 21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
12.3%
15/122 • Number of events 27 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Infections and infestations
COVID-19
5.8%
7/121 • Number of events 7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
7.4%
9/122 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Infections and infestations
Conjunctivitis
6.6%
8/121 • Number of events 14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
4.9%
6/122 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Infections and infestations
Pneumonia
5.8%
7/121 • Number of events 11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
6.6%
8/122 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Infections and infestations
Respiratory tract infection
5.8%
7/121 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
10.7%
13/122 • Number of events 16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Investigations
Alanine aminotransferase increased
12.4%
15/121 • Number of events 26 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
11.5%
14/122 • Number of events 26 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Investigations
Amylase increased
5.0%
6/121 • Number of events 25 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
5.7%
7/122 • Number of events 13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Investigations
Aspartate aminotransferase increased
9.9%
12/121 • Number of events 22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
7.4%
9/122 • Number of events 19 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Investigations
Blood alkaline phosphatase increased
6.6%
8/121 • Number of events 11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
6.6%
8/122 • Number of events 12 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Investigations
Blood creatinine increased
14.9%
18/121 • Number of events 22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
7.4%
9/122 • Number of events 26 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Investigations
Gamma-glutamyltransferase increased
6.6%
8/121 • Number of events 14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
4.9%
6/122 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Investigations
Platelet count decreased
1.7%
2/121 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
7.4%
9/122 • Number of events 21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Investigations
Weight decreased
7.4%
9/121 • Number of events 11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
7.4%
9/122 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders
Decreased appetite
19.8%
24/121 • Number of events 38 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
16.4%
20/122 • Number of events 22 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders
Hyperglycaemia
6.6%
8/121 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
6.6%
8/122 • Number of events 11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders
Hypomagnesaemia
7.4%
9/121 • Number of events 16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
7.4%
9/122 • Number of events 20 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders
Hyponatraemia
5.8%
7/121 • Number of events 11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
1.6%
2/122 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders
Arthralgia
8.3%
10/121 • Number of events 16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
9.0%
11/122 • Number of events 11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders
Back pain
6.6%
8/121 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
12.3%
15/122 • Number of events 18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
3.3%
4/121 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
7.4%
9/122 • Number of events 12 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders
Pain in extremity
5.8%
7/121 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
3.3%
4/122 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Nervous system disorders
Dizziness
7.4%
9/121 • Number of events 11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
4.9%
6/122 • Number of events 7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Nervous system disorders
Headache
6.6%
8/121 • Number of events 13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
7.4%
9/122 • Number of events 11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Cough
21.5%
26/121 • Number of events 33 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
18.0%
22/122 • Number of events 34 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
18.2%
22/121 • Number of events 41 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
17.2%
21/122 • Number of events 33 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders
Pruritus
10.7%
13/121 • Number of events 19 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
11.5%
14/122 • Number of events 14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders
Rash
13.2%
16/121 • Number of events 17 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
5.7%
7/122 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
Vascular disorders
Hypertension
7.4%
9/121 • Number of events 20 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.
4.1%
5/122 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months.
Safety population included all participants who received at least 1 dose of study treatment.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

  • Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
  • Publication restrictions are in place

Restriction type: OTHER