Trial Outcomes & Findings for A Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer (NCT NCT04177108)
NCT ID: NCT04177108
Last Updated: 2024-03-27
Results Overview
PFS was defined as the time from randomization to the first occurrence of disease progression as determined locally by RECIST or death from any cause during treatment, whichever occurs first.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
242 participants
Primary outcome timeframe
From Randomization to disease progression, study completion, or death (up to 39 months)
Results posted on
2024-03-27
Participant Flow
Participants took part in the study at 215 investigative centers from 25 November 2019 to 28 February 2023.
A total of 242 participants with Advanced triple-negative breast cancer (TNBC) were enrolled, of which 127 participants were randomized to cohort 1 {programmed death-ligand 1 (PD-L1) Non-positive} and 115 participants to cohort 2 (PD-L1 positive).
Participant milestones
| Measure |
Cohort 1 Arm A: Ipatasertib + Atezolizumab + Paclitaxel
TNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 milligrams per meter square (mg/m\^2), intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, orally (PO), once daily (QD), from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 1 Arm B: Ipatasertib + Atezolizumab Matching Placebo + Paclitaxel
TNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab-matching placebo, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + Paclitaxel
TNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib-matching placebo, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab-matching placebo, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 2 Arm A: Ipatasertib + Atezolizumab + Paclitaxel
TNBC participants with PD-L1 positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 2 Arm B: Ipatasertib Matching Placebo+ Atezolizumab + Paclitaxel
TNBC participants with PD-L1 positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib-matching placebo, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
43
|
43
|
41
|
58
|
57
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
43
|
43
|
41
|
58
|
57
|
Reasons for withdrawal
| Measure |
Cohort 1 Arm A: Ipatasertib + Atezolizumab + Paclitaxel
TNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 milligrams per meter square (mg/m\^2), intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, orally (PO), once daily (QD), from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 1 Arm B: Ipatasertib + Atezolizumab Matching Placebo + Paclitaxel
TNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab-matching placebo, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + Paclitaxel
TNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib-matching placebo, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab-matching placebo, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 2 Arm A: Ipatasertib + Atezolizumab + Paclitaxel
TNBC participants with PD-L1 positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 2 Arm B: Ipatasertib Matching Placebo+ Atezolizumab + Paclitaxel
TNBC participants with PD-L1 positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib-matching placebo, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
8
|
9
|
11
|
13
|
|
Overall Study
Physician Decision
|
23
|
15
|
18
|
29
|
23
|
|
Overall Study
Reason Not Specified
|
0
|
1
|
0
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
1
|
|
Overall Study
Death
|
16
|
19
|
13
|
17
|
18
|
Baseline Characteristics
A Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Cohort 1 Arm A: Ipatasertib + Atezolizumab + Paclitaxel
n=43 Participants
TNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 1 Arm B: Ipatasertib + Atezolizumab Matching Placebo + Paclitaxel
n=43 Participants
TNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab-matching placebo, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + Paclitaxel
n=41 Participants
TNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib-matching placebo, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab-matching placebo, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 2 Arm A: Ipatasertib + Atezolizumab + Paclitaxel
n=58 Participants
TNBC participants with PD-L1 positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 2 Arm B: Ipatasertib Matching Placebo+ Atezolizumab + Paclitaxel
n=57 Participants
TNBC participants with PD-L1 positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib-matching placebo, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.5 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
50.8 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
53.5 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
53.7 years
STANDARD_DEVIATION 12.1 • n=4 Participants
|
51.1 years
STANDARD_DEVIATION 11.7 • n=21 Participants
|
52.9 years
STANDARD_DEVIATION 11.7 • n=8 Participants
|
|
Sex/Gender, Customized
Female
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
242 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
52 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
183 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
61 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
145 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From Randomization to disease progression, study completion, or death (up to 39 months)Population: ITT population included all participants randomized in this study.
PFS was defined as the time from randomization to the first occurrence of disease progression as determined locally by RECIST or death from any cause during treatment, whichever occurs first.
Outcome measures
| Measure |
Cohort 1 Arm A: Ipatasertib + Atezolizumab + Paclitaxel
n=43 Participants
TNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 1 Arm B: Ipatasertib + Atezolizumab Matching Placebo + Paclitaxel
n=43 Participants
TNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab-matching placebo, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + Paclitaxel
n=41 Participants
TNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib-matching placebo, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab-matching placebo, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 2 Arm A: Ipatasertib + Atezolizumab + Paclitaxel
n=58 Participants
TNBC participants with PD-L1 positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 2 Arm B: Ipatasertib Matching Placebo+ Atezolizumab + Paclitaxel
n=57 Participants
TNBC participants with PD-L1 positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib-matching placebo, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
|---|---|---|---|---|---|
|
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
|
7.1 months
Interval 5.1 to 9.3
|
5.6 months
Interval 3.7 to 8.2
|
3.7 months
Interval 3.6 to 5.4
|
5.6 months
Interval 5.4 to 9.2
|
5.7 months
Interval 4.0 to 9.1
|
PRIMARY outcome
Timeframe: From randomization up to study completion or death (Up to 39 months)Population: ITT population included all participants randomized in this study.
OS was defined as the time from randomization to the time of death from any cause on study.
Outcome measures
| Measure |
Cohort 1 Arm A: Ipatasertib + Atezolizumab + Paclitaxel
n=43 Participants
TNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 1 Arm B: Ipatasertib + Atezolizumab Matching Placebo + Paclitaxel
n=43 Participants
TNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab-matching placebo, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + Paclitaxel
n=41 Participants
TNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib-matching placebo, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab-matching placebo, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 2 Arm A: Ipatasertib + Atezolizumab + Paclitaxel
n=58 Participants
TNBC participants with PD-L1 positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 2 Arm B: Ipatasertib Matching Placebo+ Atezolizumab + Paclitaxel
n=57 Participants
TNBC participants with PD-L1 positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib-matching placebo, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
|---|---|---|---|---|---|
|
Overall Survival (OS)
|
15.7 months
Interval 12.5 to
Upper limit of 95% confidence interval (CI) could not be calculated due to insufficient number of participants with events.
|
15.3 months
Interval 15.3 to
Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
16.6 months
Interval 9.6 to
Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
NA months
Interval 14.1 to
Median and upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
17.2 months
Interval 13.4 to
Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 39 monthsPopulation: Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Outcome measures
| Measure |
Cohort 1 Arm A: Ipatasertib + Atezolizumab + Paclitaxel
n=43 Participants
TNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 1 Arm B: Ipatasertib + Atezolizumab Matching Placebo + Paclitaxel
n=43 Participants
TNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab-matching placebo, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + Paclitaxel
n=41 Participants
TNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib-matching placebo, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab-matching placebo, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 2 Arm A: Ipatasertib + Atezolizumab + Paclitaxel
n=58 Participants
TNBC participants with PD-L1 positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 2 Arm B: Ipatasertib Matching Placebo+ Atezolizumab + Paclitaxel
n=57 Participants
TNBC participants with PD-L1 positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib-matching placebo, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
42 Participants
|
43 Participants
|
40 Participants
|
58 Participants
|
56 Participants
|
Adverse Events
Cohort 1 Arm A: Ipatasertib + Atezolizumab + Paclitaxel
Serious events: 14 serious events
Other events: 42 other events
Deaths: 16 deaths
Cohort 1 Arm B: Ipatasertib + Atezolizumab Matching Placebo + Paclitaxel
Serious events: 7 serious events
Other events: 42 other events
Deaths: 19 deaths
Cohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + Paclitaxel
Serious events: 7 serious events
Other events: 40 other events
Deaths: 13 deaths
Cohort 2 Arm A: Ipatasertib + Atezolizumab + Paclitaxe
Serious events: 16 serious events
Other events: 56 other events
Deaths: 18 deaths
Cohort 2 Arm B: Ipatasertib Matching Placebo+ Atezolizumab + Paclitaxel
Serious events: 9 serious events
Other events: 55 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Cohort 1 Arm A: Ipatasertib + Atezolizumab + Paclitaxel
n=43 participants at risk
TNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 milligrams per meter square (mg/m\^2), intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, orally (PO), once daily (QD), from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 1 Arm B: Ipatasertib + Atezolizumab Matching Placebo + Paclitaxel
n=43 participants at risk
TNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab-matching placebo, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + Paclitaxel
n=41 participants at risk
TNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib-matching placebo, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab-matching placebo, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 2 Arm A: Ipatasertib + Atezolizumab + Paclitaxe
n=58 participants at risk
TNBC participants with PD-L1 positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 2 Arm B: Ipatasertib Matching Placebo+ Atezolizumab + Paclitaxel
n=57 participants at risk
TNBC participants with PD-L1 positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib-matching placebo, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.7%
1/58 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
3.4%
2/58 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.7%
1/58 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.7%
1/58 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.7%
2/43 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.7%
1/58 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.7%
1/58 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
General disorders
Death
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.7%
1/58 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
General disorders
Fatigue
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
General disorders
Pyrexia
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.7%
1/58 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Immune system disorders
Hypersensitivity
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Infections and infestations
COVID-19
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Infections and infestations
COVID-19 pneumonia
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Infections and infestations
Cellulitis
|
4.7%
2/43 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Infections and infestations
Cholecystitis infective
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Infections and infestations
Clostridium colitis
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Infections and infestations
Device related infection
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.7%
1/58 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Infections and infestations
Infection
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Infections and infestations
Pyelonephritis
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Infections and infestations
Septic shock
|
4.7%
2/43 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Infections and infestations
Urinary tract infection
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.7%
1/58 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.7%
1/58 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
3.4%
2/58 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
3.4%
2/58 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Nervous system disorders
Vocal cord paresis
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.7%
1/58 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.7%
1/58 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord atrophy
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.0%
3/43 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.7%
1/58 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
Other adverse events
| Measure |
Cohort 1 Arm A: Ipatasertib + Atezolizumab + Paclitaxel
n=43 participants at risk
TNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 milligrams per meter square (mg/m\^2), intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, orally (PO), once daily (QD), from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 1 Arm B: Ipatasertib + Atezolizumab Matching Placebo + Paclitaxel
n=43 participants at risk
TNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab-matching placebo, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + Paclitaxel
n=41 participants at risk
TNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib-matching placebo, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab-matching placebo, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 2 Arm A: Ipatasertib + Atezolizumab + Paclitaxe
n=58 participants at risk
TNBC participants with PD-L1 positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
Cohort 2 Arm B: Ipatasertib Matching Placebo+ Atezolizumab + Paclitaxel
n=57 participants at risk
TNBC participants with PD-L1 positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib-matching placebo, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
34.9%
15/43 • Number of events 22 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
16.3%
7/43 • Number of events 18 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
14.6%
6/41 • Number of events 10 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
37.9%
22/58 • Number of events 36 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
21.1%
12/57 • Number of events 17 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.3%
4/43 • Number of events 5 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.7%
2/43 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.9%
2/41 • Number of events 6 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
13.8%
8/58 • Number of events 13 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
7.0%
4/57 • Number of events 7 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
34.9%
15/43 • Number of events 21 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
11.6%
5/43 • Number of events 21 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
19.5%
8/41 • Number of events 26 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
19.0%
11/58 • Number of events 36 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
15.8%
9/57 • Number of events 19 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.7%
1/58 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
7.0%
4/57 • Number of events 5 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
4.7%
2/43 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.7%
2/43 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
10.3%
6/58 • Number of events 7 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
10.5%
6/57 • Number of events 7 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.2%
3/58 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.3%
3/57 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.7%
2/43 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
9.3%
4/43 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
9.8%
4/41 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
6.9%
4/58 • Number of events 5 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
3.5%
2/57 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.6%
5/43 • Number of events 7 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
8.6%
5/58 • Number of events 7 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.3%
3/57 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Constipation
|
16.3%
7/43 • Number of events 7 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
27.9%
12/43 • Number of events 16 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
63.4%
26/41 • Number of events 29 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
27.6%
16/58 • Number of events 22 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
42.1%
24/57 • Number of events 33 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
74.4%
32/43 • Number of events 66 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
69.8%
30/43 • Number of events 71 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
36.6%
15/41 • Number of events 22 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
63.8%
37/58 • Number of events 81 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
28.1%
16/57 • Number of events 28 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.0%
3/43 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
7.0%
3/43 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
10.3%
6/58 • Number of events 8 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
7.3%
3/41 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.7%
1/58 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Nausea
|
39.5%
17/43 • Number of events 21 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
32.6%
14/43 • Number of events 16 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
22.0%
9/41 • Number of events 10 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
37.9%
22/58 • Number of events 36 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
22.8%
13/57 • Number of events 16 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
7.0%
3/43 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
14.0%
6/43 • Number of events 7 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.9%
2/41 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
12.1%
7/58 • Number of events 8 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.3%
3/57 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
16.3%
7/43 • Number of events 16 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
23.3%
10/43 • Number of events 14 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
13.8%
8/58 • Number of events 10 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
14.0%
8/57 • Number of events 9 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
General disorders
Asthenia
|
20.9%
9/43 • Number of events 10 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
14.0%
6/43 • Number of events 8 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
17.1%
7/41 • Number of events 9 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
22.4%
13/58 • Number of events 24 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
8.8%
5/57 • Number of events 5 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
General disorders
Fatigue
|
18.6%
8/43 • Number of events 12 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
23.3%
10/43 • Number of events 12 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
12.2%
5/41 • Number of events 8 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
24.1%
14/58 • Number of events 15 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
19.3%
11/57 • Number of events 11 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
General disorders
Mucosal inflammation
|
14.0%
6/43 • Number of events 7 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
7.0%
3/43 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
6.9%
4/58 • Number of events 5 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
10.5%
6/57 • Number of events 7 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
General disorders
Oedema peripheral
|
4.7%
2/43 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
9.8%
4/41 • Number of events 6 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
6.9%
4/58 • Number of events 5 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
General disorders
Pain
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
7.3%
3/41 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.2%
3/58 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
General disorders
Pyrexia
|
14.0%
6/43 • Number of events 6 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
7.0%
3/43 • Number of events 5 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.4%
1/41 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
12.1%
7/58 • Number of events 10 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
12.3%
7/57 • Number of events 8 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Infections and infestations
COVID-19
|
4.7%
2/43 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.7%
2/43 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.7%
1/58 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.3%
3/57 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Infections and infestations
Urinary tract infection
|
7.0%
3/43 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
9.3%
4/43 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.9%
2/41 • Number of events 8 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.2%
3/58 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
3.5%
2/57 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
9.3%
4/43 • Number of events 5 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.2%
3/58 • Number of events 8 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
7.0%
3/43 • Number of events 5 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
13.8%
8/58 • Number of events 11 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
8.8%
5/57 • Number of events 7 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
25.6%
11/43 • Number of events 15 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
25.6%
11/43 • Number of events 12 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
29.3%
12/41 • Number of events 15 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
20.7%
12/58 • Number of events 19 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
19.3%
11/57 • Number of events 18 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
16.3%
7/43 • Number of events 9 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
23.3%
10/43 • Number of events 14 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
24.4%
10/41 • Number of events 18 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
19.0%
11/58 • Number of events 16 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
17.5%
10/57 • Number of events 18 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
11.6%
5/43 • Number of events 7 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
14.0%
6/43 • Number of events 9 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
10.3%
6/58 • Number of events 9 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Investigations
Blood creatinine increased
|
11.6%
5/43 • Number of events 7 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.7%
2/43 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
8.6%
5/58 • Number of events 8 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
14.0%
6/43 • Number of events 14 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.2%
3/58 • Number of events 7 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
9.3%
4/43 • Number of events 5 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.7%
2/43 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
10.3%
6/58 • Number of events 7 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Investigations
Lipase increased
|
2.3%
1/43 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
8.6%
5/58 • Number of events 5 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Investigations
Lymphocyte count decreased
|
7.0%
3/43 • Number of events 16 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 9 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.2%
3/58 • Number of events 10 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Investigations
Neutrophil count decreased
|
11.6%
5/43 • Number of events 12 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
20.9%
9/43 • Number of events 14 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
12.2%
5/41 • Number of events 7 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
15.5%
9/58 • Number of events 20 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
10.5%
6/57 • Number of events 16 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Investigations
Weight decreased
|
9.3%
4/43 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.4%
1/41 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.2%
3/58 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Investigations
White blood cell count decreased
|
11.6%
5/43 • Number of events 13 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
14.0%
6/43 • Number of events 14 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.4%
1/41 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
6.9%
4/58 • Number of events 11 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
3.5%
2/57 • Number of events 10 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.0%
6/43 • Number of events 7 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
14.0%
6/43 • Number of events 6 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
14.6%
6/41 • Number of events 7 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
27.6%
16/58 • Number of events 20 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
12.3%
7/57 • Number of events 9 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
23.3%
10/43 • Number of events 12 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
9.3%
4/43 • Number of events 9 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
20.7%
12/58 • Number of events 18 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.3%
3/57 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
3.4%
2/58 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.3%
3/57 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
11.6%
5/43 • Number of events 11 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
8.6%
5/58 • Number of events 5 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.3%
1/43 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
7.0%
3/43 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.7%
1/58 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.3%
4/43 • Number of events 6 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
10.3%
6/58 • Number of events 8 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.7%
2/43 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
6.9%
4/58 • Number of events 5 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.3%
4/43 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
9.3%
4/43 • Number of events 5 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
7.3%
3/41 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
12.1%
7/58 • Number of events 8 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
7.0%
4/57 • Number of events 9 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.0%
3/43 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
9.3%
4/43 • Number of events 5 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
8.6%
5/58 • Number of events 7 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
8.8%
5/57 • Number of events 6 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.7%
2/43 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.7%
2/43 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
8.6%
5/58 • Number of events 5 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
7.3%
3/41 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.6%
5/43 • Number of events 5 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
7.0%
3/43 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
19.5%
8/41 • Number of events 9 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
15.5%
9/58 • Number of events 26 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
8.8%
5/57 • Number of events 5 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Nervous system disorders
Dizziness
|
9.3%
4/43 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
9.3%
4/43 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.9%
2/41 • Number of events 11 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
8.6%
5/58 • Number of events 5 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
7.0%
4/57 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
7.3%
3/41 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
12.1%
7/58 • Number of events 8 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
3.5%
2/57 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Nervous system disorders
Headache
|
4.7%
2/43 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
14.0%
6/43 • Number of events 6 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
7.3%
3/41 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
19.0%
11/58 • Number of events 15 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
21.1%
12/57 • Number of events 14 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
34.9%
15/43 • Number of events 19 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
18.6%
8/43 • Number of events 9 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
24.4%
10/41 • Number of events 11 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
13.8%
8/58 • Number of events 8 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
14.0%
8/57 • Number of events 9 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Nervous system disorders
Paraesthesia
|
11.6%
5/43 • Number of events 6 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
7.0%
3/43 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
7.3%
3/41 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
6.9%
4/58 • Number of events 5 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.3%
4/43 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
14.0%
6/43 • Number of events 7 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
12.2%
5/41 • Number of events 6 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
19.0%
11/58 • Number of events 11 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
15.8%
9/57 • Number of events 10 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Nervous system disorders
Polyneuropathy
|
4.7%
2/43 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
7.0%
3/43 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Psychiatric disorders
Insomnia
|
9.3%
4/43 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
14.0%
6/43 • Number of events 6 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
7.3%
3/41 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
10.3%
6/58 • Number of events 6 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
7.0%
4/57 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.7%
2/43 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
9.8%
4/41 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.2%
3/58 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
3.5%
2/57 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.3%
4/43 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
11.6%
5/43 • Number of events 5 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
6.9%
4/58 • Number of events 5 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.3%
3/57 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.7%
2/43 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
7.0%
3/43 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
9.8%
4/41 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
8.6%
5/58 • Number of events 5 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.3%
3/57 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
23.3%
10/43 • Number of events 10 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
30.2%
13/43 • Number of events 13 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
46.3%
19/41 • Number of events 19 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
31.0%
18/58 • Number of events 18 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
43.9%
25/57 • Number of events 26 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.7%
2/43 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.7%
2/43 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.3%
3/57 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.0%
3/43 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
12.2%
5/41 • Number of events 6 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
13.8%
8/58 • Number of events 9 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
14.0%
8/57 • Number of events 8 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.3%
10/43 • Number of events 11 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
23.3%
10/43 • Number of events 15 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
17.1%
7/41 • Number of events 11 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
32.8%
19/58 • Number of events 27 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
29.8%
17/57 • Number of events 35 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
9.3%
4/43 • Number of events 5 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
6.9%
4/58 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
9.3%
4/43 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.3%
3/57 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.7%
2/43 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.2%
3/58 • Number of events 6 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
7.0%
3/43 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.2%
3/58 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.0%
3/43 • Number of events 5 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.7%
2/43 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
3.4%
2/58 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
General disorders
Illness
|
7.0%
3/43 • Number of events 9 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
General disorders
Malaise
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.2%
3/58 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
General disorders
Oedema
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
6.9%
4/58 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
3.5%
2/57 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
7.0%
3/43 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/58 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Investigations
Amylase increased
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
6.9%
4/58 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
3.5%
2/57 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Investigations
Blood albumin decreased
|
2.3%
1/43 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.7%
2/43 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.2%
3/58 • Number of events 6 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Investigations
Blood cholesterol increased
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
6.9%
4/58 • Number of events 9 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
3.5%
2/57 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Investigations
Blood glucose increased
|
4.7%
2/43 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.7%
2/43 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.2%
3/58 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.7%
2/43 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.2%
3/58 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Investigations
Glycosylated haemoglobin increased
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.7%
2/43 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.2%
3/58 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.7%
2/43 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.2%
3/58 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
2.3%
1/43 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.7%
2/43 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.2%
3/58 • Number of events 6 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/57 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.0%
3/43 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.7%
1/58 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Nervous system disorders
Neurotoxicity
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.2%
3/58 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
3.5%
2/57 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.2%
3/58 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.2%
3/58 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.0%
3/43 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.4%
1/41 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.7%
1/58 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
5.2%
3/58 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.3%
4/43 • Number of events 4 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.7%
1/58 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/43 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
4.9%
2/41 • Number of events 2 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
6.9%
4/58 • Number of events 5 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
|
Vascular disorders
Lymphoedema
|
7.0%
3/43 • Number of events 3 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
2.3%
1/43 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
0.00%
0/41 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.7%
1/58 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
1.8%
1/57 • Number of events 1 • Up to 39 months
Safety-evaluable population included all randomized participants who took at least one dose of the study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights
- Publication restrictions are in place
Restriction type: OTHER