Trial Outcomes & Findings for A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (NCT NCT02366143)

NCT ID: NCT02366143

Last Updated: 2021-09-23

Results Overview

Progression Free Survival (PFS), as Determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Arm B versus Arm C in the T-effector (Teff)-high wild type (WT) population and the intent-to-treat (ITT)-WT population.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1202 participants

Primary outcome timeframe

Baseline until disease progression or death, whichever occurs first until data cut-off on 15 September 2017 (up to approximately 29 months)

Results posted on

2021-09-23

Participant Flow

Participant milestones

Participant milestones
Measure
Arm C
Bevacizumab+Paclitaxel+Carboplatin
Arm B
Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin
Arm A
Atezolizumab+Paclitaxel+Carboplatin
Overall Study
STARTED
400
400
402
Overall Study
COMPLETED
0
0
0
Overall Study
NOT COMPLETED
400
400
402

Reasons for withdrawal

Reasons for withdrawal
Measure
Arm C
Bevacizumab+Paclitaxel+Carboplatin
Arm B
Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin
Arm A
Atezolizumab+Paclitaxel+Carboplatin
Overall Study
Death
307
278
280
Overall Study
Lost to Follow-up
2
4
2
Overall Study
Physician Decision
1
2
1
Overall Study
Protocol Violation
0
0
2
Overall Study
Withdrawal by Subject
16
17
22
Overall Study
Sponsor request to withdraw/discontinue patient
0
6
0
Overall Study
Increased Microscopic RBCS on Urinalysis
0
1
0
Overall Study
Randomization Error
1
0
0
Overall Study
PI Move and Site Closure
1
0
1
Overall Study
Study Terminated By Sponsor
0
0
2
Overall Study
Sponsor request to withdraw/discontinue patient in survival follow up
70
57
52
Overall Study
Patient moved to roll-over study
1
19
28
Overall Study
Patient moved to commercial stock
0
0
1
Overall Study
Patient stopped treatment due to disease progression;didn't enter follow up due to study termination
0
0
1
Overall Study
Patient rolling over to patient assistance program
0
0
1
Overall Study
Patient continue same treatment via Post Trial Access Progarm (PTAP)
0
0
1
Overall Study
Requester's instructions
1
1
1
Overall Study
Uneligible
0
1
0
Overall Study
Post Trial Migration
0
1
0
Overall Study
Patient moving onto PTAP commercial stock
0
1
0
Overall Study
Patient switched to PTAP
0
1
0
Overall Study
Patient moved to commercial atezolizumab use
0
11
7

Baseline Characteristics

A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Arm C
n=400 Participants
Bevacizumab+Paclitaxel+Carboplatin
Arm B
n=400 Participants
Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin
Arm A
n=402 Participants
Atezolizumab+Paclitaxel+Carboplatin
Total
n=1202 Participants
Total of all reporting groups
Age, Continuous
63.1 Years
STANDARD_DEVIATION 9.3 • n=5 Participants
63.0 Years
STANDARD_DEVIATION 9.5 • n=7 Participants
62.3 Years
STANDARD_DEVIATION 9.2 • n=5 Participants
62.8 Years
STANDARD_DEVIATION 9.3 • n=4 Participants
Sex: Female, Male
Female
161 Participants
n=5 Participants
160 Participants
n=7 Participants
161 Participants
n=5 Participants
482 Participants
n=4 Participants
Sex: Female, Male
Male
239 Participants
n=5 Participants
240 Participants
n=7 Participants
241 Participants
n=5 Participants
720 Participants
n=4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=5 Participants
3 Participants
n=7 Participants
0 Participants
n=5 Participants
4 Participants
n=4 Participants
Race (NIH/OMB)
Asian
46 Participants
n=5 Participants
56 Participants
n=7 Participants
48 Participants
n=5 Participants
150 Participants
n=4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Black or African American
12 Participants
n=5 Participants
3 Participants
n=7 Participants
9 Participants
n=5 Participants
24 Participants
n=4 Participants
Race (NIH/OMB)
White
335 Participants
n=5 Participants
322 Participants
n=7 Participants
331 Participants
n=5 Participants
988 Participants
n=4 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
3 Participants
n=7 Participants
4 Participants
n=5 Participants
7 Participants
n=4 Participants
Race (NIH/OMB)
Unknown or Not Reported
6 Participants
n=5 Participants
13 Participants
n=7 Participants
10 Participants
n=5 Participants
29 Participants
n=4 Participants

PRIMARY outcome

Timeframe: Baseline until disease progression or death, whichever occurs first until data cut-off on 15 September 2017 (up to approximately 29 months)

Population: Teff-high WT population is defined as the Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. ITT-WT population is defined as the ITT population excluding patients with an activating EGFR mutation or ALK translocation.

Progression Free Survival (PFS), as Determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Arm B versus Arm C in the T-effector (Teff)-high wild type (WT) population and the intent-to-treat (ITT)-WT population.

Outcome measures

Outcome measures
Measure
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
n=356 Participants
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=336 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Progression Free Survival (PFS), as Determined by the Investigator in Arm B Versus Arm C in the Teff-high WT Population and ITT-WT Population
Teff-high WT Population
11.3 Months
Interval 9.1 to 13.0
6.8 Months
Interval 5.9 to 7.4
Progression Free Survival (PFS), as Determined by the Investigator in Arm B Versus Arm C in the Teff-high WT Population and ITT-WT Population
ITT-WT Population
8.3 Months
Interval 7.7 to 9.8
6.8 Months
Interval 6.0 to 7.1

PRIMARY outcome

Timeframe: Baseline until death until data cut-off on 22 January 2018 (up to approximately 34 months)

Population: ITT-WT population is defined as the ITT population excluding patients with an activating EGFR mutation or ALK translocation.

Overall Survival (OS) in Arm B Versus Arm C in ITT-WT Population

Outcome measures

Outcome measures
Measure
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
n=359 Participants
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=337 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Overall Survival (OS) in Arm B Versus Arm C in ITT-WT Population
19.2 Months
Interval 17.0 to 23.8
14.7 Months
Interval 13.3 to 16.9

PRIMARY outcome

Timeframe: Baseline until death (up approximately 53 months)

Population: ITT-WT population is defined as the ITT population excluding patients with an activating EGFR mutation or ALK translocation.

Overall Survival (OS) in Arm A Versus Arm C in ITT-WT Population

Outcome measures

Outcome measures
Measure
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
n=350 Participants
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=338 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Overall Survival (OS) in Arm A Versus Arm C in ITT-WT Population
19.0 Months
Interval 15.7 to 21.5
14.7 Months
Interval 12.9 to 17.1

SECONDARY outcome

Timeframe: Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)

Population: Teff-high WT population is defined as the Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. ITT-WT population is defined as the ITT population excluding patients with an activating EGFR mutation or ALK translocation.

PFS, as determined by the independent review facility (IRF) Using RECIST v1.1 in Arm B versus Arm C in the T-effector (Teff)-high wild type (WT) population and the intent-to-treat (ITT)-WT population.

Outcome measures

Outcome measures
Measure
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
n=356 Participants
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=336 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
PFS, as Determined by the Independent Review Facility (IRF) in Arm B Versus Arm C in Teff-High-WT Population and ITT-WT Population
Teff-high WT Population
10.7 Months
Interval 8.4 to 13.0
7.0 Months
Interval 6.1 to 8.1
PFS, as Determined by the Independent Review Facility (IRF) in Arm B Versus Arm C in Teff-High-WT Population and ITT-WT Population
ITT-WT Population
8.5 Months
Interval 7.7 to 9.7
7.0 Months
Interval 6.3 to 8.0

SECONDARY outcome

Timeframe: Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)

Population: Teff-high population is defined as the patients in the ITT population with Teff signature expression \>=-1.91. ITT population is defined as all randomized patients, regardless of receipt of the assigned treatment.

PFS, as determined by the investigator according to RECIST v1.1, in Arm B versus C in the Teff high population and ITT population.

Outcome measures

Outcome measures
Measure
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
n=400 Participants
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=400 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
PFS, as Determined by the Investigator in Arm B Versus Arm C in Teff High Population and ITT Population
Teff-high Population
11.3 Months
Interval 9.1 to 13.0
6.8 Months
Interval 5.8 to 7.3
PFS, as Determined by the Investigator in Arm B Versus Arm C in Teff High Population and ITT Population
ITT Population
8.3 Months
Interval 7.9 to 9.8
6.8 Months
Interval 6.0 to 7.1

SECONDARY outcome

Timeframe: Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)

Population: Teff-high WT population is defined as the Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. ITT-WT population is defined as the ITT population excluding patients with an activating EGFR mutation or ALK translocation.

PFS, as determined by the investigator according to RECIST v1.1, in Arm A versus B in the Teff high-WT population and ITT-WT population.

Outcome measures

Outcome measures
Measure
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
n=348 Participants
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=356 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
PFS, as Determined by the Investigator in Arm A Versus Arm B in Teff High-WT Population and ITT-WT Population
Teff-high WT
6.3 Months
Interval 5.6 to 7.8
11.3 Months
Interval 9.1 to 13.0
PFS, as Determined by the Investigator in Arm A Versus Arm B in Teff High-WT Population and ITT-WT Population
ITT-WT
6.3 Months
Interval 5.6 to 7.0
8.3 Months
Interval 7.7 to 9.8

SECONDARY outcome

Timeframe: Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)

Population: The PD-L1-selected WT populations are defined as the PD-L1-selected populations (TC2/3 or IC2/3 population or TC1/2/3 or IC1/2/3 population) excluding patients with a sensitizing EGFR mutation or ALK translocation.

PFS as Determined by the Investigator according to RECIST v1.1, in Arm B Versus Arm C by PD-L1 Subgroup: TC2/3 or 1C2/3 and TC1/2/3 or IC1/2/3 (ITT-WT Population)

Outcome measures

Outcome measures
Measure
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
n=190 Participants
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=164 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
PFS, as Determined by the Investigator in Arm B Versus Arm C by PD-L1 Subgroup
TC2/3 or IC2/3 Subgroup
11.1 Months
Interval 8.3 to 13.0
6.8 Months
Interval 5.8 to 7.7
PFS, as Determined by the Investigator in Arm B Versus Arm C by PD-L1 Subgroup
TC1/2/3 or IC1/2/3 Subgroup
11.0 Months
Interval 8.3 to 12.5
6.8 Months
Interval 5.8 to 7.3

SECONDARY outcome

Timeframe: Baseline until death (up to approximately 34 months)

Population: The PD-L1-selected WT populations are defined as the PD-L1-selected populations (TC2/3 or IC2/3 population or TC1/2/3 or IC1/2/3 population) excluding patients with a sensitizing EGFR mutation or ALK translocation.

OS in Arm B Versus Arm C by PD-L1 Subgroup: TC2/3 or 1C2/3 and TC1/2/3 or IC1/2/3 (ITT-WT Population)

Outcome measures

Outcome measures
Measure
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
n=192 Participants
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=165 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
OS in Arm B Versus Arm C by PD-L1 Subgroup
TC 2/3 or IC2/3 Population
22.2 Months
Interval 17.0 to 26.1
16.7 Months
Interval 10.5 to 24.2
OS in Arm B Versus Arm C by PD-L1 Subgroup
TC1/2/3 or IC1/2/3 Population
22.5 Months
Interval 18.2 to 26.1
16.4 Months
Interval 11.2 to 22.9

SECONDARY outcome

Timeframe: Baseline until death (up approximately 53 months)

Population: PD-L1 WT populations are defined as the PD-L1 populations (TC2/3 or IC2/3 population or TC1/2/3 or IC1/2/3 population) excluding patients with an activating EGFR mutation or ALK translocation.

OS in Arm A Versus Arm C by PD-L1 Subgroup: TC2/3 or 1C2/3 and TC1/2/3 or IC1/2/3 (ITT-WT Population)

Outcome measures

Outcome measures
Measure
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
n=185 Participants
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=165 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
OS in Arm A Versus Arm C by PD-L1 Subgroup
TC2/3 or IC2/3 Population
26.1 Months
Interval 20.5 to 40.0
17.0 Months
Interval 10.3 to 22.9
OS in Arm A Versus Arm C by PD-L1 Subgroup
TC1/2/3 or IC1/2/3 Population
24.4 Months
Interval 20.2 to 28.1
16.0 Months
Interval 11.2 to 20.1

SECONDARY outcome

Timeframe: Baseline until death (up to approximately 34 months)

Population: Teff-high WT population, defined as the Teff-high population excluding patients with activating EGFR mutation or ALK translocation. Teff-high population, defined as participants in the ITT population with Teff signature expression \>=-1.91. ITT population, defined as all randomized patients, regardless of receipt of the assigned treatment.

Outcome measures

Outcome measures
Measure
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
n=400 Participants
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=400 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
OS in Arm B Versus Arm C in Teff High-WT Population, Teff High Population, and ITT Population
Teff High-WT Population
25.0 Months
Interval 17.8 to
Upper confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
16.7 Months
Interval 12.4 to
Upper confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
OS in Arm B Versus Arm C in Teff High-WT Population, Teff High Population, and ITT Population
Teff High Population
25.2 Months
Interval 19.1 to
Upper confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
16.7 Months
Interval 12.4 to
Upper confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
OS in Arm B Versus Arm C in Teff High-WT Population, Teff High Population, and ITT Population
ITT Population
19.8 Months
Interval 17.4 to 24.2
14.9 Months
Interval 13.4 to 17.1

SECONDARY outcome

Timeframe: Baseline until death (up approximately 53 months)

Population: Teff-high WT population, defined as Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. Teff-high population, defined as patients in the ITT population with Teff signature expression \>=-1.91. ITT population is defined as all randomized patients, regardless of receipt of the assigned treatment.

Outcome measures

Outcome measures
Measure
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
n=402 Participants
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=400 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
OS in Arm A Versus Arm C in Teff High-WT Population, Teff High Population, and ITT Population
Teff-high WT Population
21.3 Months
Interval 17.6 to 26.3
16.3 Months
Interval 11.2 to 22.3
OS in Arm A Versus Arm C in Teff High-WT Population, Teff High Population, and ITT Population
Teff-high Population
21.0 Months
Interval 17.1 to 26.0
16.7 Months
Interval 11.4 to 21.6
OS in Arm A Versus Arm C in Teff High-WT Population, Teff High Population, and ITT Population
ITT Population
19.0 Months
Interval 16.3 to 21.5
15.0 Months
Interval 13.4 to 17.1

SECONDARY outcome

Timeframe: Baseline until death (up approximately 53 months)

Population: Teff-high WT population is defined as the Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. ITT-WT population is defined as the ITT population excluding patients with an activating EGFR mutation or ALK translocation.

Outcome measures

Outcome measures
Measure
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
n=350 Participants
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=359 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
OS in Arm A Versus Arm B in Teff High-WT Population and ITT-WT Population
ITT-WT Population
19.0 Months
Interval 15.7 to 21.5
19.5 Months
Interval 17.0 to 22.2
OS in Arm A Versus Arm B in Teff High-WT Population and ITT-WT Population
Teff High-WT Population
21.3 Months
Interval 17.6 to 26.3
25.8 Months
Interval 19.1 to 32.6

SECONDARY outcome

Timeframe: Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)

Population: Teff-high WT population is defined as the Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. ITT-WT population is defined as the ITT population excluding patients with an activating EGFR mutation or ALK translocation.

DOR, as determined by investigator according to RECIST v1.1 in Arm B versus Arm C in the Teff high-WT population and the ITT-WT population.

Outcome measures

Outcome measures
Measure
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
n=224 Participants
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=159 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Duration of Response (DOR), as Determined By Investigator in Arm B Versus Arm C
Teff high-WT Population
11.2 Months
Interval 9.7 to 15.7
5.7 Months
Interval 4.9 to 7.0
Duration of Response (DOR), as Determined By Investigator in Arm B Versus Arm C
ITT-WT Population
9.0 Months
Interval 6.9 to 11.4
5.7 Months
Interval 5.1 to 6.5

SECONDARY outcome

Timeframe: Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)

Population: Teff-high WT population is defined as the Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. ITT-WT population is defined as the ITT population excluding patients with an activating EGFR mutation or ALK translocation.

Percentage of Participants With an Objective Response (OR) (Complete Response \[CR\] or Partial Response \[PR\]) as Determined by the Investigator using RECIST v1.1 in the Teff-High-WT population and ITT-WT population.

Outcome measures

Outcome measures
Measure
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
n=347 Participants
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=353 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=331 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator in the Teff-High-WT Population and ITT-WT Population
Teff-high WT Population
54.0 Percentage
69.3 Percentage
53.5 Percentage
Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator in the Teff-High-WT Population and ITT-WT Population
ITT-WT Population
49.3 Percentage
63.5 Percentage
48.0 Percentage

SECONDARY outcome

Timeframe: Baseline to 2 years or death, whichever occurs first.

Population: Teff-high WT population is defined as the Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. ITT-WT population is defined as the ITT population excluding patients with an activating EGFR mutation or ALK translocation.

OS at 1- and 2-year landmark timepoints in Teff-high WT population and ITT-WT population.

Outcome measures

Outcome measures
Measure
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
n=235 Participants
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=196 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
OS Rates at Years 1 and 2 in Arm B Versus Arm C
2-Year ITT-WT Population
43.42 Percentage
Interval 36.94 to 49.9
33.71 Percentage
Interval 27.44 to 39.98
OS Rates at Years 1 and 2 in Arm B Versus Arm C
1-Year Teff-high WT Population
68.63 Percentage
Interval 61.28 to 75.98
58.74 Percentage
Interval 50.03 to 67.45
OS Rates at Years 1 and 2 in Arm B Versus Arm C
1-Year ITT-WT Population
67.32 Percentage
Interval 62.41 to 72.22
60.63 Percentage
Interval 55.34 to 65.93
OS Rates at Years 1 and 2 in Arm B Versus Arm C
2-Year Teff-high WT Population
52.03 Percentage
Interval 43.12 to 60.94
41.70 Percentage
Interval 31.55 to 51.85

SECONDARY outcome

Timeframe: Baseline to 2 years or death, whichever occurs first.

Population: Teff-high WT population is defined as the Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. ITT-WT population is defined as the ITT population excluding patients with an activating EGFR mutation or ALK translocation.

OS at 1- and 2-year landmark timepoints in Teff-high WT population and ITT-WT population.

Outcome measures

Outcome measures
Measure
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
n=222 Participants
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=197 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
OS Rates at Years 1 and 2 in Arm A Versus Arm C
1-Year Teff-high WT Population
67.48 Percentage
Interval 60.29 to 74.68
56.92 Percentage
Interval 48.32 to 65.53
OS Rates at Years 1 and 2 in Arm A Versus Arm C
2-Year Teff-high WT Population
46.01 Percentage
Interval 38.36 to 53.66
38.74 Percentage
Interval 30.26 to 47.22
OS Rates at Years 1 and 2 in Arm A Versus Arm C
1-Year ITT-WT Population
64.06 Percentage
Interval 59.02 to 69.11
59.89 Percentage
Interval 54.61 to 65.17
OS Rates at Years 1 and 2 in Arm A Versus Arm C
2-Year ITT-WT Population
41.45 Percentage
Interval 36.26 to 46.64
31.79 Percentage
Interval 26.75 to 36.82

SECONDARY outcome

Timeframe: Baseline up to approximately 29 months

Population: Teff-high WT population is defined as the Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. ITT-WT population is defined as the ITT population excluding patients with an activating EGFR mutation or ALK translocation.

EORTC QLQ-C30 is a validated \& reliable self-report measure (Aaronson et al.1993;Fitzsimmons et al.1999) that consists of 30 questions that assess 5 aspects of patient functioning (physical,emotional,role, cognitive,and social), 3 symptom scales (fatigue,nausea \& vomiting, pain),global health/quality of life,and six single items (dyspnea,insomnia, appetite loss,constipation,diarrhea, and financial difficulties). EORTC QLQ-C30 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life);however a high score for a symptom scale or item represents a high level of symptomatology or problems. A ≥10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al.1998).

Outcome measures

Outcome measures
Measure
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
n=348 Participants
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=356 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=336 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms Determined by European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Score
Dyspnea in Teff-high WT Population
NA Months
Value is not available due to an insufficient number of participants with the event. Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
NA Months
Value is not available due to an insufficient number of participants with the event. Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
NA Months
Value is not available due to an insufficient number of participants with the event. Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms Determined by European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Score
Dyspnea in ITT-WT Population
NA Months
Value is not available due to an insufficient number of participants with the event. Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
NA Months
Value is not available due to an insufficient number of participants with the event. Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
NA Months
Value is not available due to an insufficient number of participants with the event. Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.

SECONDARY outcome

Timeframe: Baseline up to approximately 29 months

Population: Teff-high WT population is defined as the Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. ITT-WT population is defined as the ITT population excluding patients with an activating EGFR mutation or ALK translocation.

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

Outcome measures

Outcome measures
Measure
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
n=348 Participants
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=356 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=336 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC Quality-of-Life Questionnaire-Core Lung Cancer Module 13 (QLQ-LC13) Score
Cough in Teff-high WT Population
NA Months
Value is not available due to an insufficient number of participants with the event. Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
NA Months
Interval 21.0 to
Value is not available due to an insufficient number of participants with the event. Upper confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
NA Months
Value is not available due to an insufficient number of participants with the event. Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC Quality-of-Life Questionnaire-Core Lung Cancer Module 13 (QLQ-LC13) Score
Dyspnea in Teff-high WT Population
NA Months
Interval 5.6 to
Value is not available due to an insufficient number of participants with the event. Upper confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
NA Months
Value is not available due to an insufficient number of participants with the event. Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
NA Months
Interval 6.3 to
Value is not available due to an insufficient number of participants with the event. Upper confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC Quality-of-Life Questionnaire-Core Lung Cancer Module 13 (QLQ-LC13) Score
Chest Pain in Teff-high WT Population
NA Months
Value is not available due to an insufficient number of participants with the event. Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
22.2 Months
Interval 22.2 to
Upper confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
18.4 Months
Interval 18.4 to
Upper confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC Quality-of-Life Questionnaire-Core Lung Cancer Module 13 (QLQ-LC13) Score
Arm and/or Shoulder Pain in Teff-high WT
NA Months
Interval 18.3 to
Value is not available due to an insufficient number of participants with the event. Upper confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
19.5 Months
Interval 12.5 to
Upper confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
NA Months
Interval 12.7 to
Value is not available due to an insufficient number of participants with the event. Upper confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC Quality-of-Life Questionnaire-Core Lung Cancer Module 13 (QLQ-LC13) Score
Cough in ITT-WT Population
NA Months
Value is not available due to an insufficient number of participants with the event. Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
NA Months
Interval 21.0 to
Value is not available due to an insufficient number of participants with the event. Upper confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
NA Months
Value is not available due to an insufficient number of participants with the event. Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC Quality-of-Life Questionnaire-Core Lung Cancer Module 13 (QLQ-LC13) Score
Dyspnea in ITT-WT Population
21.9 Months
Interval 9.7 to
Upper confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
NA Months
Value is not available due to an insufficient number of participants with the event. Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
NA Months
Interval 10.0 to
Value is not available due to an insufficient number of participants with the event. Upper confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC Quality-of-Life Questionnaire-Core Lung Cancer Module 13 (QLQ-LC13) Score
Arm and/or Shoulder Pain in ITT-WT
NA Months
Interval 18.3 to
Value is not available due to an insufficient number of participants with the event. Upper confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
19.5 Months
Interval 15.2 to
Upper confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
NA Months
Value is not available due to an insufficient number of participants with the event. Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC Quality-of-Life Questionnaire-Core Lung Cancer Module 13 (QLQ-LC13) Score
Pain in Chest in ITT-WT Population
NA Months
Value is not available due to an insufficient number of participants with the event. Median is not reached and the confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
NA Months
Interval 22.2 to
Value is not available due to an insufficient number of participants with the event. Upper confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
NA Months
Interval 18.4 to
Value is not available due to an insufficient number of participants with the event. Upper confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.

SECONDARY outcome

Timeframe: Baseline up to approximately 29 months

Population: No participants were analyzed due to psychometric properties within the NSCLC population are still being determined. Due to quality issues data not analyzed.

The SILC (Symptoms in Lung Cancer) scale was used to assess patient-reported severity of lung cancer symptoms (chest pain, dyspnea, and cough). The SILC scale is a 9-item content validated self-report measure of lung cancer symptoms. It measures severity of cough, dyspnea, and chest pain with a symptom severity score. The SILC questionnaire comprises three individual symptoms (dyspnea, cough, chest pain) and are scored at the individual symptom level, thus have a dyspnea score, chest pain score, and cough score. Each individual symptom score is calculated as the average of responses for the symptom items \[e.g. Chest Pain Score=mean (item 1; item 2)\]. An increase in score is suggestive of a worsening in symptomology (i.e. frequency or severity). A score change of ≥0.3 points for the dyspnea and cough symptom scores is considered to be clinically significant; whereas a score change of ≥0.5 points for the chest pain score is considered to be clinically significant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to data cutoff date 7 December 2020 (up to approximately 68 months)

Population: Safety population included all treated patients, defined as randomized patients who received any amount of any component of study treatment.

Percentage of participants with at least one adverse event.

Outcome measures

Outcome measures
Measure
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
n=394 Participants
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=393 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=400 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Percentage of Participants With Adverse Events
99.0 Percentage
98.2 Percentage
97.8 Percentage

SECONDARY outcome

Timeframe: Baseline up to approximately 29 months

Population: The baseline ADA-evaluable population for each study treatment included patients who had a baseline ADA result. The post-baseline ADA-evaluable population for each study treatment included patients who had at least one post-baseline ADA result and had received at least on dose of that study treatment.

Outcome measures

Outcome measures
Measure
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
n=389 Participants
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=376 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
4.6 Percentage of Participants
2.9 Percentage of Participants

SECONDARY outcome

Timeframe: Day 1 of Cycle 1 and 3 (Cycle length=21 days)

Population: The pharmacokinetic-evaluable population is defined as all patients who received any dose of atezolizumab, bevacizumab, carboplatin, or paclitaxel and who had evaluable PK samples post-dose.

The predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes.

Outcome measures

Outcome measures
Measure
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
n=378 Participants
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=364 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Maximum Observed Serum Concentration (Cmax) of Atezolizumab in Arm A and Arm B
Cycle 1 Day 1
410 mcg/mL
Standard Deviation 157
414 mcg/mL
Standard Deviation 127
Maximum Observed Serum Concentration (Cmax) of Atezolizumab in Arm A and Arm B
Cycle 3 Day 1
498 mcg/mL
Standard Deviation 160
540 mcg/mL
Standard Deviation 198

SECONDARY outcome

Timeframe: Day 21 of Cycles 1, 2 3, and 7 (Cycle length=21 days)

Population: The pharmacokinetic-evaluable population is defined as all patients who received any dose of atezolizumab, bevacizumab, carboplatin, or paclitaxel and who had evaluable PK samples post-dose.

Outcome measures

Outcome measures
Measure
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
n=354 Participants
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=345 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Minimum Observed Serum Concentration (Cmin) of Atezolizumab Prior to Infusion in Arm A and Arm B
Cycle 1 Day 21
76.4 mcg/mL
Standard Deviation 37.7
80.8 mcg/mL
Standard Deviation 41.4
Minimum Observed Serum Concentration (Cmin) of Atezolizumab Prior to Infusion in Arm A and Arm B
Cycle 2 Day 21
119 mcg/mL
Standard Deviation 55.7
130 mcg/mL
Standard Deviation 57.1
Minimum Observed Serum Concentration (Cmin) of Atezolizumab Prior to Infusion in Arm A and Arm B
Cycle 3 Day 21
146 mcg/mL
Standard Deviation 58.9
160 mcg/mL
Standard Deviation 102
Minimum Observed Serum Concentration (Cmin) of Atezolizumab Prior to Infusion in Arm A and Arm B
Cycle 7 Day 21
219 mcg/mL
Standard Deviation 89.6
220 mcg/mL
Standard Deviation 99.0

SECONDARY outcome

Timeframe: Predose (same day of treatment administration), 5-10 minutes before end of carboplatin infusion, 1 h after carboplatin infusion (infusion duration=15 to 30 minutes) on D1 of Cy1,3 (Cycle length=21 days)

Population: The pharmacokinetic-evaluable population is defined as all patients who received any dose of atezolizumab, bevacizumab, carboplatin, or paclitaxel and who had evaluable PK samples post-dose.

Outcome measures

Outcome measures
Measure
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
n=28 Participants
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=35 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=24 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Plasma Concentrations for Carboplatin in Arm A, Arm B, and Arm C
Cy3D1 Before End of Infusion
20900 ng/mL
Standard Deviation 8330
18700 ng/mL
Standard Deviation 9410
20600 ng/mL
Standard Deviation 12900
Plasma Concentrations for Carboplatin in Arm A, Arm B, and Arm C
Cy1D1 Pre-dose
NA ng/mL
Standard Deviation NA
Predose of Cycle 1 Day 1 administration of Carboplatin.
NA ng/mL
Standard Deviation NA
Predose of Cycle 1 Day 1 administration of Carboplatin.
NA ng/mL
Standard Deviation NA
Predose of Cycle 1 Day 1 administration of Carboplatin.
Plasma Concentrations for Carboplatin in Arm A, Arm B, and Arm C
Cy1D1 Before End of Infusion
18300 ng/mL
Standard Deviation 9610
18300 ng/mL
Standard Deviation 11900
17200 ng/mL
Standard Deviation 9860
Plasma Concentrations for Carboplatin in Arm A, Arm B, and Arm C
Cy1D1 After Infusion
11700 ng/mL
Standard Deviation 5570
13900 ng/mL
Standard Deviation 14300
10100 ng/mL
Standard Deviation 5320
Plasma Concentrations for Carboplatin in Arm A, Arm B, and Arm C
Cy2D21
176 ng/mL
Standard Deviation 82.9
190 ng/mL
Standard Deviation 113
143 ng/mL
Standard Deviation 73.0
Plasma Concentrations for Carboplatin in Arm A, Arm B, and Arm C
Cy3D1 After Infusion
11700 ng/mL
Standard Deviation 6990
12200 ng/mL
Standard Deviation 7480
10400 ng/mL
Standard Deviation 4150

SECONDARY outcome

Timeframe: Predose (same day of treatment administration), 5-10 minutes before end of paclitaxel infusion, 1 h after paclitaxel infusion (infusion duration=3 h) on D1 of Cy1,3 (Cycle length=21 days)

Population: The pharmacokinetic-evaluable population is defined as all patients who received any dose of atezolizumab, bevacizumab, carboplatin, or paclitaxel and who had evaluable PK samples post-dose.

Outcome measures

Outcome measures
Measure
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
n=28 Participants
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=35 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=24 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Plasma Concentrations for Paclitaxel in Arm A, Arm B, and Arm C
Cy1D1 Pre-dose
NA ng/mL
Standard Deviation NA
Predose of Cycle 1 Day 1 administration of Paclitaxel.
NA ng/mL
Standard Deviation NA
Predose of Cycle 1 Day 1 administration of Paclitaxel.
NA ng/mL
Standard Deviation NA
Predose of Cycle 1 Day 1 administration of Paclitaxel.
Plasma Concentrations for Paclitaxel in Arm A, Arm B, and Arm C
Cy1D1 Before End of Infusion
4850 ng/mL
Standard Deviation 2800
6440 ng/mL
Standard Deviation 3640
5560 ng/mL
Standard Deviation 2590
Plasma Concentrations for Paclitaxel in Arm A, Arm B, and Arm C
Cy1D1 After Infusion
2300 ng/mL
Standard Deviation 2790
2490 ng/mL
Standard Deviation 3020
1980 ng/mL
Standard Deviation 1780
Plasma Concentrations for Paclitaxel in Arm A, Arm B, and Arm C
Cy2D21
NA ng/mL
Standard Deviation NA
Mean or SD is not reported because more than half of the samples at the specified timepoint are below the limit of quantification.
NA ng/mL
Standard Deviation NA
Mean or SD is not reported because more than half of the samples at the specified timepoint are below the limit of quantification.
Plasma Concentrations for Paclitaxel in Arm A, Arm B, and Arm C
Cy3D1 Before End Of Infusion
5810 ng/mL
Standard Deviation 3610
7810 ng/mL
Standard Deviation 4510
7810 ng/mL
Standard Deviation 5160
Plasma Concentrations for Paclitaxel in Arm A, Arm B, and Arm C
Cy3D1 After Infusion
1800 ng/mL
Standard Deviation 1660
2990 ng/mL
Standard Deviation 5830
1930 ng/mL
Standard Deviation 1380

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 3 Day 1 (Cycle length=21 days)

Population: The pharmacokinetic-evaluable population is defined as all patients who received any dose of atezolizumab, bevacizumab, carboplatin, or paclitaxel and who had evaluable PK samples post-dose.

Outcome measures

Outcome measures
Measure
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
n=205 Participants
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=215 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Cmax of Bevacizumab in Arm B and Arm C
Cycle 1 Day 1
329 mcg/mL
Standard Deviation 129
323 mcg/mL
Standard Deviation 95.0
Cmax of Bevacizumab in Arm B and Arm C
Cycle 3 Day 1
413 mcg/mL
Standard Deviation 126
430 mcg/mL
Standard Deviation 123

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 2 Day 21 (Cycle length=21 days)

Population: The pharmacokinetic-evaluable population is defined as all patients who received any dose of atezolizumab, bevacizumab, carboplatin, or paclitaxel and who had evaluable PK samples post-dose.

Outcome measures

Outcome measures
Measure
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
n=325 Participants
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
n=348 Participants
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Cmin of Bevacizumab in Arm B and Arm C
Cycle 1 Day 1
NA mcg/mL
Standard Deviation NA
Predose of Cycle 1 Day 1 administration of Bevacizumab.
NA mcg/mL
Standard Deviation NA
Predose of Cycle 1 Day 1 administration of Bevacizumab.
Cmin of Bevacizumab in Arm B and Arm C
Cycle 2 Day 21
98.0 mcg/mL
Standard Deviation 50.9
90.4 mcg/mL
Standard Deviation 36.8

Adverse Events

Arm C (Bev+CP)

Serious events: 142 serious events
Other events: 381 other events
Deaths: 311 deaths

Arm B (Atezo+Bev+CP)

Serious events: 190 serious events
Other events: 375 other events
Deaths: 285 deaths

Arm A (Atezo+CP)

Serious events: 170 serious events
Other events: 385 other events
Deaths: 293 deaths

Serious adverse events

Serious adverse events
Measure
Arm C (Bev+CP)
n=394 participants at risk
Bevacizumab+Paclitaxel+Carboplatin
Arm B (Atezo+Bev+CP)
n=393 participants at risk
Atezolizumab+Bevacizumab+Paclitaxel+Carboplatin
Arm A (Atezo+CP)
n=400 participants at risk
Atezolizumab+Paclitaxel+Carboplatin
Metabolism and nutrition disorders
HYPERCALCAEMIA
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Metabolism and nutrition disorders
HYPERGLYCAEMIA
0.25%
1/394 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Metabolism and nutrition disorders
HYPOKALAEMIA
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Metabolism and nutrition disorders
HYPONATRAEMIA
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Musculoskeletal and connective tissue disorders
ARTHRALGIA
0.51%
2/394 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.75%
3/400 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Musculoskeletal and connective tissue disorders
BACK PAIN
0.76%
3/394 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Musculoskeletal and connective tissue disorders
BONE PAIN
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Musculoskeletal and connective tissue disorders
COMPARTMENT SYNDROME
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Musculoskeletal and connective tissue disorders
FLANK PAIN
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.50%
2/400 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Musculoskeletal and connective tissue disorders
MYALGIA
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Musculoskeletal and connective tissue disorders
OSTEOLYSIS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Musculoskeletal and connective tissue disorders
SOFT TISSUE NECROSIS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Musculoskeletal and connective tissue disorders
SPINAL PAIN
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Musculoskeletal and connective tissue disorders
VERTEBRAL FORAMINAL STENOSIS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA GASTRIC
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-CELL LYMPHOMA
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER NEOPLASM
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER TRANSITIONAL CELL CARCINOMA
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MARROW HYPERPLASIA
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MENINGIOMA
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO MENINGES
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PSEUDOPROGRESSION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
ATAXIA
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
CEREBRAL HAEMORRHAGE
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
CEREBRAL INFARCTION
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
CEREBRAL ISCHAEMIA
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
CEREBROVASCULAR ACCIDENT
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
1.3%
5/393 • Number of events 5 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.50%
2/400 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
COGNITIVE DISORDER
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
DEPRESSED LEVEL OF CONSCIOUSNESS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
DIZZINESS
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
DIZZINESS POSTURAL
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
DYSAESTHESIA
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
ENCEPHALOPATHY
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
FOCAL DYSCOGNITIVE SEIZURES
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
HAEMORRHAGE INTRACRANIAL
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
HEADACHE
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
HEMIPARESIS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
ISCHAEMIC STROKE
1.0%
4/394 • Number of events 4 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.50%
2/400 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
LOSS OF CONSCIOUSNESS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
METABOLIC ENCEPHALOPATHY
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
NEUROPATHY PERIPHERAL
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
PARTIAL SEIZURES
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.50%
2/400 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
0.51%
2/394 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME
0.51%
2/394 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
PRESYNCOPE
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
SEIZURE
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
1.3%
5/393 • Number of events 5 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.50%
2/400 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
SOMNOLENCE
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
SPINAL CORD COMPRESSION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
SYNCOPE
0.51%
2/394 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Psychiatric disorders
ALCOHOL WITHDRAWAL SYNDROME
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Psychiatric disorders
ANXIETY
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Psychiatric disorders
BIPOLAR DISORDER
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Psychiatric disorders
CONFUSIONAL STATE
0.51%
2/394 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Psychiatric disorders
DELIRIUM
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Psychiatric disorders
DELUSION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Psychiatric disorders
MENTAL STATUS CHANGES
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Psychiatric disorders
PSYCHOTIC DISORDER
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Psychiatric disorders
SUICIDAL IDEATION
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Renal and urinary disorders
ACUTE KIDNEY INJURY
0.76%
3/394 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.76%
3/393 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.50%
2/400 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Renal and urinary disorders
GLOMERULONEPHROPATHY
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Renal and urinary disorders
HAEMATURIA
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Renal and urinary disorders
NEPHROLITHIASIS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Renal and urinary disorders
PRERENAL FAILURE
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Renal and urinary disorders
RENAL FAILURE
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.76%
3/393 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Renal and urinary disorders
RENAL IMPAIRMENT
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Renal and urinary disorders
RENAL INJURY
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Renal and urinary disorders
TUBULOINTERSTITIAL NEPHRITIS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.75%
3/400 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
BRONCHOSTENOSIS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.51%
2/394 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.76%
3/393 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.75%
3/400 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
COUGH
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.76%
3/393 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
1.5%
6/394 • Number of events 6 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
1.0%
4/400 • Number of events 4 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
0.51%
2/394 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
2.0%
8/393 • Number of events 8 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.75%
3/400 • Number of events 4 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
HICCUPS
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
HYPOXIA
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.50%
2/400 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
IMMUNE-MEDIATED PNEUMONITIS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
0.51%
2/394 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.75%
3/400 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
PLEURISY
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
PLEURITIC PAIN
0.25%
1/394 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
1.8%
7/393 • Number of events 7 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
2.0%
8/400 • Number of events 8 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
0.51%
2/394 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
1.0%
4/400 • Number of events 4 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
2.0%
8/394 • Number of events 8 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
1.3%
5/393 • Number of events 5 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
2.0%
8/400 • Number of events 8 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
PULMONARY HAEMORRHAGE
1.0%
4/394 • Number of events 4 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
PULMONARY NECROSIS
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.50%
2/400 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Skin and subcutaneous tissue disorders
DERMATITIS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.75%
3/400 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Skin and subcutaneous tissue disorders
PEMPHIGOID
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Skin and subcutaneous tissue disorders
RASH
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.75%
3/400 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Surgical and medical procedures
VERTEBROPLASTY
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Vascular disorders
ANEURYSM
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Vascular disorders
AORTIC DISSECTION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Vascular disorders
ARTERIAL OCCLUSIVE DISEASE
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Vascular disorders
DEEP VEIN THROMBOSIS
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Vascular disorders
DIABETIC VASCULAR DISORDER
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Vascular disorders
EMBOLISM
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.50%
2/400 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Vascular disorders
EMBOLISM VENOUS
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Vascular disorders
HAEMATOMA
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Vascular disorders
HYPERTENSION
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Vascular disorders
HYPOTENSION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Vascular disorders
LYMPHOEDEMA
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Vascular disorders
ORTHOSTATIC HYPOTENSION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Vascular disorders
PERIPHERAL ARTERY THROMBOSIS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Vascular disorders
PERIPHERAL ISCHAEMIA
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Vascular disorders
PERIPHERAL VASCULAR DISORDER
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Vascular disorders
THROMBOSIS
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Vascular disorders
VENOUS THROMBOSIS LIMB
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Investigations
HEPATIC ENZYME INCREASED
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Investigations
LIPASE INCREASED
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Investigations
NEUTROPHIL COUNT DECREASED
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Investigations
PLATELET COUNT DECREASED
0.51%
2/394 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Investigations
TRANSAMINASES INCREASED
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Investigations
TROPONIN INCREASED
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
SEPTIC SHOCK
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.50%
2/400 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
STAPHYLOCOCCAL BACTERAEMIA
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Investigations
WEIGHT DECREASED
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Investigations
WHITE BLOOD CELL COUNT DECREASED
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Metabolism and nutrition disorders
DECREASED APPETITE
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Blood and lymphatic system disorders
ANAEMIA
1.0%
4/394 • Number of events 4 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
1.3%
5/393 • Number of events 5 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
1.2%
5/400 • Number of events 6 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Blood and lymphatic system disorders
BONE MARROW FAILURE
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
4.3%
17/394 • Number of events 18 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
6.9%
27/393 • Number of events 30 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
3.2%
13/400 • Number of events 13 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Blood and lymphatic system disorders
LEUKOPENIA
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Blood and lymphatic system disorders
MYELOSUPPRESSION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Blood and lymphatic system disorders
NEUTROPENIA
0.51%
2/394 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
1.0%
4/393 • Number of events 4 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Blood and lymphatic system disorders
NORMOCHROMIC ANAEMIA
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Blood and lymphatic system disorders
PANCYTOPENIA
0.51%
2/394 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Blood and lymphatic system disorders
SPONTANEOUS HAEMATOMA
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Blood and lymphatic system disorders
THROMBOCYTOPENIA
0.51%
2/394 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
1.5%
6/393 • Number of events 6 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
0.76%
3/394 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Cardiac disorders
ATRIAL FIBRILLATION
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.50%
2/400 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Cardiac disorders
ATRIAL FLUTTER
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Cardiac disorders
ATRIOVENTRICULAR BLOCK SECOND DEGREE
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Cardiac disorders
AUTOIMMUNE MYOCARDITIS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Cardiac disorders
CARDIAC ARREST
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Cardiac disorders
CARDIAC FAILURE
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Cardiac disorders
CORONARY ARTERY DISEASE
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Cardiac disorders
LEFT VENTRICULAR DYSFUNCTION
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Cardiac disorders
MYOCARDIAL INFARCTION
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.50%
2/400 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Cardiac disorders
MYOCARDIAL ISCHAEMIA
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Cardiac disorders
PERICARDIAL EFFUSION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Cardiac disorders
PERICARDITIS
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Cardiac disorders
TACHYARRHYTHMIA
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Cardiac disorders
VENTRICULAR TACHYCARDIA
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Endocrine disorders
ADRENAL INSUFFICIENCY
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Endocrine disorders
ADRENOCORTICAL INSUFFICIENCY ACUTE
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Endocrine disorders
DIABETES INSIPIDUS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Endocrine disorders
HYPOPHYSITIS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Endocrine disorders
HYPOTHYROIDISM
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Endocrine disorders
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Endocrine disorders
SECONDARY ADRENOCORTICAL INSUFFICIENCY
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Eye disorders
OPTIC NEUROPATHY
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
ABDOMINAL PAIN
0.76%
3/394 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.50%
2/400 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
COLITIS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
1.5%
6/393 • Number of events 6 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
COLITIS ISCHAEMIC
0.51%
2/394 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
CONSTIPATION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
DIARRHOEA
0.76%
3/394 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
2.5%
10/393 • Number of events 11 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
2.0%
8/400 • Number of events 8 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
DIVERTICULAR PERFORATION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
DUODENAL ULCER
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
DYSPHAGIA
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.50%
2/400 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
FAECALOMA
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
FOOD POISONING
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
GASTRIC HAEMORRHAGE
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
GASTRITIS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
1.0%
4/393 • Number of events 4 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.50%
2/400 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
GLOSSODYNIA
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
ILEUS PARALYTIC
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
INGUINAL HERNIA
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
INTESTINAL ANGINA
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
INTESTINAL HAEMORRHAGE
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
INTESTINAL INFARCTION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
INTESTINAL ISCHAEMIA
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
INTESTINAL PERFORATION
0.51%
2/394 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
IRRITABLE BOWEL SYNDROME
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
LARGE INTESTINAL HAEMORRHAGE
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
LARGE INTESTINE PERFORATION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
NAUSEA
0.76%
3/394 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
1.8%
7/393 • Number of events 7 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
OESOPHAGEAL FOOD IMPACTION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
PANCREATITIS ACUTE
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
VOMITING
0.76%
3/394 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
1.3%
5/393 • Number of events 5 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
1.0%
4/400 • Number of events 5 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
General disorders
ASTHENIA
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
General disorders
CATHETER SITE ERYTHEMA
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
General disorders
CHEST PAIN
1.5%
6/394 • Number of events 7 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
1.0%
4/393 • Number of events 4 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
General disorders
COMPLICATION ASSOCIATED WITH DEVICE
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
General disorders
DEATH
0.51%
2/394 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
0.51%
2/394 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
General disorders
INFLUENZA LIKE ILLNESS
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
General disorders
INFUSION SITE EXTRAVASATION
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
General disorders
MUCOSAL INFLAMMATION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
General disorders
NON-CARDIAC CHEST PAIN
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
General disorders
OEDEMA PERIPHERAL
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
General disorders
PAIN
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
General disorders
PYREXIA
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
2.0%
8/393 • Number of events 8 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
1.5%
6/400 • Number of events 6 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Hepatobiliary disorders
CHOLANGITIS
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.76%
3/393 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Hepatobiliary disorders
CHOLANGITIS ACUTE
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Hepatobiliary disorders
CHOLELITHIASIS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Hepatobiliary disorders
HEPATITIS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Hepatobiliary disorders
HEPATOMEGALY
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Hepatobiliary disorders
HEPATOTOXICITY
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Immune system disorders
ANAPHYLACTIC REACTION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.50%
2/400 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Immune system disorders
DRUG HYPERSENSITIVITY
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.50%
2/400 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Immune system disorders
HYPERSENSITIVITY
0.51%
2/394 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
ABDOMINAL SEPSIS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
ANAL ABSCESS
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
BACTERAEMIA
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
BACTERIAL INFECTION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
BONE ABSCESS
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
BRONCHITIS
0.51%
2/394 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
1.0%
4/393 • Number of events 4 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
BURSITIS INFECTIVE
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
CELLULITIS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
CHRONIC SINUSITIS
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
CLOSTRIDIUM DIFFICILE INFECTION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
DEVICE RELATED INFECTION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.50%
2/400 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
DIVERTICULITIS
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
EMPYEMA
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.50%
2/400 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
LARGE INTESTINE INFECTION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
ENCEPHALITIS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
ENDOCARDITIS BACTERIAL
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
ENTERITIS INFECTIOUS
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
ENTEROCOLITIS BACTERIAL
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
FEBRILE INFECTION
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
GASTROENTERITIS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
GASTROENTERITIS CLOSTRIDIAL
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
HAEMORRHAGIC PNEUMONIA
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
HEPATITIS A
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
HEPATITIS C
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
HERPES ZOSTER
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.50%
2/400 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
INFECTED SKIN ULCER
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
INFECTION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
INFECTIOUS PLEURAL EFFUSION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
INFLUENZA
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
KLEBSIELLA SEPSIS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.75%
3/400 • Number of events 4 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
NEUTROPENIC SEPSIS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
OSTEOMYELITIS
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
PARAINFLUENZAE VIRUS INFECTION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
PAROTITIS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
PNEUMONIA
4.6%
18/394 • Number of events 19 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
7.1%
28/393 • Number of events 30 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
5.2%
21/400 • Number of events 23 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
PNEUMONIA ADENOVIRAL
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
PNEUMONIA BACTERIAL
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.76%
3/393 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
PROSTATIC ABSCESS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
PYOPNEUMOTHORAX
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS BRONCHITIS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS INFECTION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
RESPIRATORY TRACT INFECTION
0.76%
3/394 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
1.0%
4/393 • Number of events 4 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.50%
2/400 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
RESPIRATORY TRACT INFECTION FUNGAL
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
SALMONELLOSIS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
SCROTAL ABSCESS
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
SEPSIS
1.3%
5/394 • Number of events 5 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.76%
3/393 • Number of events 4 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.75%
3/400 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Injury, poisoning and procedural complications
WOUND COMPLICATION
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Investigations
ALANINE AMINOTRANSFERASE INCREASED
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Investigations
C-REACTIVE PROTEIN INCREASED
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Investigations
GENERAL PHYSICAL CONDITION ABNORMAL
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
STAPHYLOCOCCAL INFECTION
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
TOOTH ABSCESS
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Investigations
BLOOD PRESSURE INCREASED
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
URINARY TRACT INFECTION
0.76%
3/394 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.76%
3/393 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
1.0%
4/400 • Number of events 4 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
VASCULAR DEVICE INFECTION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
VIRAL INFECTION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.76%
3/393 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Injury, poisoning and procedural complications
FALL
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Injury, poisoning and procedural complications
FEMUR FRACTURE
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.50%
2/400 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Injury, poisoning and procedural complications
FRACTURE
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Injury, poisoning and procedural complications
HIP FRACTURE
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.50%
2/400 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Injury, poisoning and procedural complications
HUMERUS FRACTURE
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.75%
3/400 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Injury, poisoning and procedural complications
PROCEDURAL COMPLICATION
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.51%
2/393 • Number of events 2 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Injury, poisoning and procedural complications
PROCEDURAL PAIN
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Injury, poisoning and procedural complications
RIB FRACTURE
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/400 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Injury, poisoning and procedural complications
STERNAL FRACTURE
0.25%
1/394 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/393 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Metabolism and nutrition disorders
DEHYDRATION
1.5%
6/394 • Number of events 6 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
1.8%
7/393 • Number of events 9 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.75%
3/400 • Number of events 3 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Metabolism and nutrition disorders
FAILURE TO THRIVE
0.00%
0/394 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.25%
1/393 • Number of events 1 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
0.00%
0/400 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.

Other adverse events

Other adverse events
Measure
Arm C (Bev+CP)
n=394 participants at risk
Bevacizumab+Paclitaxel+Carboplatin
Arm B (Atezo+Bev+CP)
n=393 participants at risk
Atezolizumab+Bevacizumab+Paclitaxel+Carboplatin
Arm A (Atezo+CP)
n=400 participants at risk
Atezolizumab+Paclitaxel+Carboplatin
Blood and lymphatic system disorders
ANAEMIA
26.4%
104/394 • Number of events 124 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
29.5%
116/393 • Number of events 134 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
36.5%
146/400 • Number of events 183 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Blood and lymphatic system disorders
LEUKOPENIA
3.6%
14/394 • Number of events 17 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
3.6%
14/393 • Number of events 20 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
5.0%
20/400 • Number of events 35 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Blood and lymphatic system disorders
NEUTROPENIA
17.8%
70/394 • Number of events 107 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
18.3%
72/393 • Number of events 111 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
15.0%
60/400 • Number of events 85 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Blood and lymphatic system disorders
THROMBOCYTOPENIA
11.4%
45/394 • Number of events 64 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
13.5%
53/393 • Number of events 74 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
12.2%
49/400 • Number of events 78 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Endocrine disorders
HYPOTHYROIDISM
3.3%
13/394 • Number of events 13 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
12.7%
50/393 • Number of events 56 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
8.2%
33/400 • Number of events 40 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
ABDOMINAL PAIN
5.1%
20/394 • Number of events 24 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
9.2%
36/393 • Number of events 48 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
7.2%
29/400 • Number of events 36 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
CONSTIPATION
23.4%
92/394 • Number of events 115 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
31.0%
122/393 • Number of events 151 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
25.8%
103/400 • Number of events 128 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
DIARRHOEA
24.9%
98/394 • Number of events 133 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
31.8%
125/393 • Number of events 221 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
20.5%
82/400 • Number of events 137 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
DRY MOUTH
1.5%
6/394 • Number of events 6 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
5.1%
20/393 • Number of events 22 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
3.2%
13/400 • Number of events 16 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
2.3%
9/394 • Number of events 11 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
5.1%
20/393 • Number of events 20 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
2.8%
11/400 • Number of events 13 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
NAUSEA
31.5%
124/394 • Number of events 177 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
37.9%
149/393 • Number of events 223 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
32.5%
130/400 • Number of events 210 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
STOMATITIS
6.1%
24/394 • Number of events 30 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
13.7%
54/393 • Number of events 73 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
5.8%
23/400 • Number of events 27 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Gastrointestinal disorders
VOMITING
17.0%
67/394 • Number of events 105 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
18.1%
71/393 • Number of events 99 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
17.2%
69/400 • Number of events 92 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
General disorders
ASTHENIA
20.3%
80/394 • Number of events 107 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
21.4%
84/393 • Number of events 143 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
19.0%
76/400 • Number of events 127 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
General disorders
CHEST PAIN
7.1%
28/394 • Number of events 32 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
8.9%
35/393 • Number of events 37 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
9.5%
38/400 • Number of events 44 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
General disorders
FATIGUE
27.2%
107/394 • Number of events 125 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
34.9%
137/393 • Number of events 157 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
27.8%
111/400 • Number of events 129 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
General disorders
MALAISE
2.8%
11/394 • Number of events 13 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
6.9%
27/393 • Number of events 43 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
5.0%
20/400 • Number of events 27 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
General disorders
MUCOSAL INFLAMMATION
6.1%
24/394 • Number of events 27 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
9.7%
38/393 • Number of events 42 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
2.5%
10/400 • Number of events 10 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
General disorders
OEDEMA PERIPHERAL
4.8%
19/394 • Number of events 20 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
8.9%
35/393 • Number of events 42 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
7.2%
29/400 • Number of events 33 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
General disorders
PAIN
4.3%
17/394 • Number of events 17 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
6.6%
26/393 • Number of events 31 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
5.5%
22/400 • Number of events 23 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
General disorders
PYREXIA
8.6%
34/394 • Number of events 44 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
17.0%
67/393 • Number of events 88 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
13.2%
53/400 • Number of events 66 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
BRONCHITIS
4.1%
16/394 • Number of events 17 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
7.1%
28/393 • Number of events 37 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
3.8%
15/400 • Number of events 16 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
NASOPHARYNGITIS
4.3%
17/394 • Number of events 18 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
6.9%
27/393 • Number of events 34 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
7.8%
31/400 • Number of events 50 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
PNEUMONIA
3.8%
15/394 • Number of events 17 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
4.8%
19/393 • Number of events 22 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
5.2%
21/400 • Number of events 23 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
4.1%
16/394 • Number of events 20 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
9.4%
37/393 • Number of events 56 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
6.0%
24/400 • Number of events 43 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Infections and infestations
URINARY TRACT INFECTION
7.1%
28/394 • Number of events 37 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
8.9%
35/393 • Number of events 57 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
9.2%
37/400 • Number of events 51 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Investigations
ALANINE AMINOTRANSFERASE INCREASED
5.1%
20/394 • Number of events 24 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
7.6%
30/393 • Number of events 45 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
5.5%
22/400 • Number of events 26 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
4.6%
18/394 • Number of events 19 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
7.6%
30/393 • Number of events 48 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
5.5%
22/400 • Number of events 29 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Investigations
NEUTROPHIL COUNT DECREASED
8.6%
34/394 • Number of events 72 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
12.5%
49/393 • Number of events 87 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
8.2%
33/400 • Number of events 64 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Investigations
PLATELET COUNT DECREASED
11.2%
44/394 • Number of events 76 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
14.5%
57/393 • Number of events 84 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
10.2%
41/400 • Number of events 59 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Investigations
WEIGHT DECREASED
10.7%
42/394 • Number of events 46 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
13.2%
52/393 • Number of events 56 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
7.2%
29/400 • Number of events 32 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Investigations
WHITE BLOOD CELL COUNT DECREASED
5.1%
20/394 • Number of events 39 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
6.6%
26/393 • Number of events 42 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
4.2%
17/400 • Number of events 27 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Metabolism and nutrition disorders
DECREASED APPETITE
21.8%
86/394 • Number of events 102 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
30.3%
119/393 • Number of events 157 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
25.0%
100/400 • Number of events 129 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Metabolism and nutrition disorders
DEHYDRATION
3.8%
15/394 • Number of events 16 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
8.4%
33/393 • Number of events 42 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
1.8%
7/400 • Number of events 7 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Metabolism and nutrition disorders
HYPOKALAEMIA
4.1%
16/394 • Number of events 18 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
9.2%
36/393 • Number of events 47 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
6.0%
24/400 • Number of events 30 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
6.3%
25/394 • Number of events 29 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
14.0%
55/393 • Number of events 76 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
9.5%
38/400 • Number of events 49 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Metabolism and nutrition disorders
HYPONATRAEMIA
4.3%
17/394 • Number of events 20 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
5.9%
23/393 • Number of events 32 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
3.2%
13/400 • Number of events 14 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Musculoskeletal and connective tissue disorders
ARTHRALGIA
25.9%
102/394 • Number of events 155 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
33.1%
130/393 • Number of events 227 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
26.2%
105/400 • Number of events 175 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Musculoskeletal and connective tissue disorders
BACK PAIN
10.9%
43/394 • Number of events 50 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
14.5%
57/393 • Number of events 67 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
12.8%
51/400 • Number of events 70 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Musculoskeletal and connective tissue disorders
BONE PAIN
4.8%
19/394 • Number of events 19 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
5.9%
23/393 • Number of events 33 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
4.0%
16/400 • Number of events 18 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
1.8%
7/394 • Number of events 8 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
5.1%
20/393 • Number of events 24 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
2.5%
10/400 • Number of events 10 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Musculoskeletal and connective tissue disorders
MYALGIA
13.5%
53/394 • Number of events 81 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
17.6%
69/393 • Number of events 118 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
16.8%
67/400 • Number of events 104 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
8.1%
32/394 • Number of events 43 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
12.7%
50/393 • Number of events 63 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
11.2%
45/400 • Number of events 52 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
DIZZINESS
6.6%
26/394 • Number of events 31 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
6.9%
27/393 • Number of events 34 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
7.0%
28/400 • Number of events 39 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
DYSGEUSIA
4.8%
19/394 • Number of events 24 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
6.1%
24/393 • Number of events 27 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
3.8%
15/400 • Number of events 16 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
HEADACHE
13.5%
53/394 • Number of events 65 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
17.8%
70/393 • Number of events 87 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
10.2%
41/400 • Number of events 49 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
NEUROPATHY PERIPHERAL
17.0%
67/394 • Number of events 77 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
23.4%
92/393 • Number of events 105 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
26.0%
104/400 • Number of events 117 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
PARAESTHESIA
11.2%
44/394 • Number of events 50 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
13.5%
53/393 • Number of events 59 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
9.2%
37/400 • Number of events 42 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
13.7%
54/394 • Number of events 59 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
16.5%
65/393 • Number of events 73 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
14.5%
58/400 • Number of events 65 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Psychiatric disorders
ANXIETY
5.6%
22/394 • Number of events 23 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
7.9%
31/393 • Number of events 31 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
5.8%
23/400 • Number of events 23 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Psychiatric disorders
DEPRESSION
3.3%
13/394 • Number of events 13 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
6.4%
25/393 • Number of events 26 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
3.8%
15/400 • Number of events 16 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Psychiatric disorders
INSOMNIA
9.6%
38/394 • Number of events 41 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
10.7%
42/393 • Number of events 43 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
12.5%
50/400 • Number of events 56 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Renal and urinary disorders
PROTEINURIA
16.0%
63/394 • Number of events 81 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
20.4%
80/393 • Number of events 128 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
2.2%
9/400 • Number of events 13 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
COUGH
19.5%
77/394 • Number of events 94 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
21.9%
86/393 • Number of events 107 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
20.5%
82/400 • Number of events 99 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
4.6%
18/394 • Number of events 19 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
6.9%
27/393 • Number of events 27 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
2.8%
11/400 • Number of events 12 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
15.2%
60/394 • Number of events 66 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
17.0%
67/393 • Number of events 81 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
21.5%
86/400 • Number of events 107 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
21.8%
86/394 • Number of events 108 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
17.0%
67/393 • Number of events 89 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
4.2%
17/400 • Number of events 22 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
4.6%
18/394 • Number of events 21 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
5.3%
21/393 • Number of events 24 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
4.0%
16/400 • Number of events 27 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
2.5%
10/394 • Number of events 10 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
5.6%
22/393 • Number of events 25 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
2.2%
9/400 • Number of events 10 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Skin and subcutaneous tissue disorders
ALOPECIA
45.7%
180/394 • Number of events 183 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
47.8%
188/393 • Number of events 195 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
45.0%
180/400 • Number of events 182 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Skin and subcutaneous tissue disorders
DRY SKIN
2.3%
9/394 • Number of events 9 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
7.4%
29/393 • Number of events 31 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
6.0%
24/400 • Number of events 28 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Skin and subcutaneous tissue disorders
PRURITUS
6.3%
25/394 • Number of events 29 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
14.8%
58/393 • Number of events 76 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
13.0%
52/400 • Number of events 72 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Skin and subcutaneous tissue disorders
RASH
7.1%
28/394 • Number of events 34 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
18.3%
72/393 • Number of events 92 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
17.8%
71/400 • Number of events 94 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
Vascular disorders
HYPERTENSION
22.1%
87/394 • Number of events 102 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
26.5%
104/393 • Number of events 149 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.
4.0%
16/400 • Number of events 16 • From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Results disclosure agreements

  • Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
  • Publication restrictions are in place

Restriction type: OTHER