Trial Outcomes & Findings for A Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab in Participants With Solid Tumors (NCT NCT03264066)
NCT ID: NCT03264066
Last Updated: 2021-05-11
Results Overview
Objective response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive tumor assessments ≥4 weeks apart, as determined by the investigators using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
87 participants
Primary outcome timeframe
Up to approximately 31 months
Results posted on
2021-05-11
Participant Flow
Enrollment took place in six countries: Republic of Korea, Belgium, Germany, United Kingdom, Hungary and United States. No participants were enrolled in Cohort 7. Participants in long term follow up and who continued to receive treatment(s) in a post-trial access program are designated in Participant Flow as "Study terminated by Sponsor".
Participants with advanced solid tumors were included in the study: squamous cell carcinoma of head and neck (SCCHN), urothelial carcinoma (UC), and renal cell carcinoma (RCC).
Participant milestones
| Measure |
Cohort 1 - SCCHN - Treatment Naive
In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 2 - UC - Treatment Naive
In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 3 - RCC - Treatment Naive
In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 4 - SCCHN - Previous Treatment Exposure
In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 5 - UC - Previous Treatment Exposure
In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 6 - RCC - Previous Treatment Exposure
In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
17
|
20
|
7
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
20
|
20
|
17
|
20
|
7
|
3
|
Reasons for withdrawal
| Measure |
Cohort 1 - SCCHN - Treatment Naive
In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 2 - UC - Treatment Naive
In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 3 - RCC - Treatment Naive
In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 4 - SCCHN - Previous Treatment Exposure
In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 5 - UC - Previous Treatment Exposure
In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 6 - RCC - Previous Treatment Exposure
In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Death
|
12
|
12
|
8
|
10
|
6
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Progressive Disease
|
0
|
2
|
1
|
0
|
0
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
5
|
5
|
8
|
5
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
5
|
0
|
0
|
Baseline Characteristics
A Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab in Participants With Solid Tumors
Baseline characteristics by cohort
| Measure |
Cohort 1 - SCCHN - Treatment Naive
n=20 Participants
In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 2 - UC - Treatment Naive
n=20 Participants
In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 3 - RCC - Treatment Naive
n=17 Participants
In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 4 - SCCHN - Previous Treatment Exposure
n=20 Participants
In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 5 - UC - Previous Treatment Exposure
n=7 Participants
In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 6 - RCC - Previous Treatment Exposure
n=3 Participants
In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
Adults (18-64 years)
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
44 Participants
n=115 Participants
|
|
Age, Customized
From 65-84 years
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
42 Participants
n=115 Participants
|
|
Age, Customized
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
21 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
66 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
80 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
24 Participants
n=115 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=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
63 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
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=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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=10 Participants
|
0 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 31 monthsPopulation: The intent-to-treat (ITT) population included all participants enrolled in the study.
Objective response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive tumor assessments ≥4 weeks apart, as determined by the investigators using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions.
Outcome measures
| Measure |
Cohort 4 - SCCHN - Previous Treatment Exposure
n=20 Participants
In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 5 - UC - Previous Treatment Exposure
n=7 Participants
In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 6 - RCC - Previous Treatment Exposure
n=3 Participants
In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 1 - SCCHN - Treatment Naive
n=20 Participants
In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 2 - UC - Treatment Naive
n=20 Participants
In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 3 - RCC - Treatment Naive
n=17 Participants
In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
0 percentage of participants
Interval 0.0 to 2.5
|
0 percentage of participants
Interval 0.0 to 7.14
|
0 percentage of participants
Interval 0.0 to 16.67
|
20.0 percentage of participants
Interval 0.0 to 40.03
|
30.0 percentage of participants
Interval 7.42 to 52.58
|
17.6 percentage of participants
Interval 0.0 to 38.71
|
SECONDARY outcome
Timeframe: Up to approximately 31 monthsPopulation: The ITT population included all participants enrolled in the study.
Overall survival was defined as the time from enrollment to death from any cause. The median for OS is Kaplan-Meier estimate. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Outcome measures
| Measure |
Cohort 4 - SCCHN - Previous Treatment Exposure
n=20 Participants
In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 5 - UC - Previous Treatment Exposure
n=7 Participants
In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 6 - RCC - Previous Treatment Exposure
n=3 Participants
In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 1 - SCCHN - Treatment Naive
n=20 Participants
In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 2 - UC - Treatment Naive
n=20 Participants
In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 3 - RCC - Treatment Naive
n=17 Participants
In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
7.7 months
Interval 4.0 to
NA=not estimable
|
5.9 months
Interval 3.1 to 12.5
|
NA months
Interval 5.9 to
NA=not estimable
|
16.8 months
Interval 6.9 to 25.8
|
18.7 months
Interval 11.0 to 26.2
|
21.7 months
Interval 17.4 to
NA=not estimable
|
SECONDARY outcome
Timeframe: Up to approximately 31 monthsPopulation: The ITT population included all participants enrolled in the study.
PFS was defined as the time from enrollment to the first occurrence of disease progression as determined by the investigator(s), using RECIST v1.1, or to death from any cause, whichever occurs first. Disease progression was defined as ≥20% increase in in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions.
Outcome measures
| Measure |
Cohort 4 - SCCHN - Previous Treatment Exposure
n=20 Participants
In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 5 - UC - Previous Treatment Exposure
n=7 Participants
In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 6 - RCC - Previous Treatment Exposure
n=3 Participants
In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 1 - SCCHN - Treatment Naive
n=20 Participants
In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 2 - UC - Treatment Naive
n=20 Participants
In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 3 - RCC - Treatment Naive
n=17 Participants
In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS)
|
3.6 months
Interval 0.0 to 9.0
|
2.1 months
Interval 1.0 to 4.0
|
2.7 months
Interval 1.0 to 4.0
|
5.5 months
Interval 2.0 to 26.0
|
3.4 months
Interval 2.0 to 26.0
|
3.4 months
Interval 1.0 to 28.0
|
SECONDARY outcome
Timeframe: Up to approximately 22 monthsPopulation: ITT population: all participants enrolled in the study. Median DOR is presented at the time of primary analysis. DOR analyses were not performed at final analysis because Kaplan-Meier was not estimable at primary analysis due to too few events in Cohorts 1 and 3. There were no subsequent events in Cohorts 1 and 3. Cohorts 4-6 had no events.
DOR was defined as the time from the first occurrence of a documented, confirmed objective response to disease progression as determined by the investigator, using RECIST v1.1, or to death from any cause, whichever occurs first. Objective response was defined as a complete response (CR) or a partial response (PR) on two consecutive tumor assessments ≥4 weeks apart. CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions. Disease progression was defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions. Presented here is median DOR at the time of primary analysis. The median for the duration of response is Kaplan-Meier estimate. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Outcome measures
| Measure |
Cohort 4 - SCCHN - Previous Treatment Exposure
In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 5 - UC - Previous Treatment Exposure
In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 6 - RCC - Previous Treatment Exposure
In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 1 - SCCHN - Treatment Naive
n=20 Participants
In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 2 - UC - Treatment Naive
n=20 Participants
In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 3 - RCC - Treatment Naive
n=17 Participants
In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|---|
|
Duration of Response (DOR)
|
—
|
—
|
—
|
NA days
NA=not estimable: Kaplan-Meier was not estimable because there were too few events in Cohort 1.
|
149.0 days
Interval 125.0 to 173.0
|
NA days
NA=not estimable: Kaplan-Meier was not estimable because there were too few events in Cohort 3.
|
SECONDARY outcome
Timeframe: At 16 weeksPopulation: The ITT population included all participants enrolled in the study.
DCR was defined as the percentage of participants with a complete response (CR), a partial response (PR), or stable disease at 16 weeks as determined by the investigator using RECIST v1.1. CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions. Stable disease was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for disease progression. Disease progression was defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions.
Outcome measures
| Measure |
Cohort 4 - SCCHN - Previous Treatment Exposure
n=20 Participants
In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 5 - UC - Previous Treatment Exposure
n=7 Participants
In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 6 - RCC - Previous Treatment Exposure
n=3 Participants
In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 1 - SCCHN - Treatment Naive
n=20 Participants
In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 2 - UC - Treatment Naive
n=20 Participants
In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 3 - RCC - Treatment Naive
n=17 Participants
In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR)
|
25.0 percentage of participants
Interval 3.52 to 46.48
|
0 percentage of participants
Interval 0.0 to 7.14
|
0 percentage of participants
Interval 0.0 to 16.67
|
50.0 percentage of participants
Interval 25.59 to 74.41
|
40.0 percentage of participants
Interval 16.03 to 63.97
|
23.5 percentage of participants
Interval 0.42 to 46.63
|
SECONDARY outcome
Timeframe: Up to approximately 31 monthsPopulation: The safety population included all enrolled participants who received at least one dose of study drug.
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Outcome measures
| Measure |
Cohort 4 - SCCHN - Previous Treatment Exposure
n=20 Participants
In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 5 - UC - Previous Treatment Exposure
n=7 Participants
In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 6 - RCC - Previous Treatment Exposure
n=3 Participants
In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 1 - SCCHN - Treatment Naive
n=20 Participants
In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 2 - UC - Treatment Naive
n=19 Participants
In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 3 - RCC - Treatment Naive
n=17 Participants
In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
20 participants
|
7 participants
|
3 participants
|
20 participants
|
19 participants
|
17 participants
|
SECONDARY outcome
Timeframe: Day 15 of Cycle 3 (cycle is 28 days): 2-4 hours after cobimetinib dosePopulation: Pharmacokinetic (PK) analysis population consisted of participants with sufficient data to enable estimation of key parameters, with participants grouped according to treatment received.
Cmax is the maximum (or peak) concentration that a study drug achieves in the body.
Outcome measures
| Measure |
Cohort 4 - SCCHN - Previous Treatment Exposure
In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 5 - UC - Previous Treatment Exposure
In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 6 - RCC - Previous Treatment Exposure
In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 1 - SCCHN - Treatment Naive
n=33 Participants
In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 2 - UC - Treatment Naive
In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 3 - RCC - Treatment Naive
In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Cobimetinib
|
—
|
—
|
—
|
285 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 56.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15 of Cycle 3 (cycle is 28 days): prior to cobimetinib dosePopulation: PK analysis population consisted of participants with sufficient data to enable estimation of key parameters, with participants grouped according to treatment received.
Cmin is the minimum (or trough) concentration that a study drug achieves in the body.
Outcome measures
| Measure |
Cohort 4 - SCCHN - Previous Treatment Exposure
In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 5 - UC - Previous Treatment Exposure
In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 6 - RCC - Previous Treatment Exposure
In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 1 - SCCHN - Treatment Naive
n=30 Participants
In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 2 - UC - Treatment Naive
In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 3 - RCC - Treatment Naive
In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|---|
|
Minimum Plasma Concentration (Cmin) of Cobimetinib
|
—
|
—
|
—
|
174 ng/mL
Geometric Coefficient of Variation 152
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 minutes following end of atezolizumab infusion on Day 15 of Cycle 3 (each cycle is 28 days)Population: PK analysis population consisted of participants with sufficient data to enable estimation of key parameters, with participants grouped according to treatment received.
Cmax is the maximum (or peak) concentration that a study drug achieves in the body.
Outcome measures
| Measure |
Cohort 4 - SCCHN - Previous Treatment Exposure
In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 5 - UC - Previous Treatment Exposure
In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 6 - RCC - Previous Treatment Exposure
In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 1 - SCCHN - Treatment Naive
n=40 Participants
In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 2 - UC - Treatment Naive
In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 3 - RCC - Treatment Naive
In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of Atezolizumab
|
—
|
—
|
—
|
417000 ng/mL
Geometric Coefficient of Variation 50.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to atezolizumab infusion on Day 1 of Cycles (each cycle is 28 days) 2, 4, 8, 12, and 16, Day 15 of Cycle 3Population: PK analysis population consisted of participants with sufficient data to enable estimation of key parameters, with participants grouped according to treatment received.
Cmin is the minimum (or trough) concentration that a study drug achieves in the body.
Outcome measures
| Measure |
Cohort 4 - SCCHN - Previous Treatment Exposure
In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 5 - UC - Previous Treatment Exposure
In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 6 - RCC - Previous Treatment Exposure
In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 1 - SCCHN - Treatment Naive
n=61 Participants
In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 2 - UC - Treatment Naive
In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 3 - RCC - Treatment Naive
In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|---|
|
Minimum Serum Concentration (Cmin) of Atezolizumab
|
—
|
—
|
—
|
112000 ng/mL
Geometric Coefficient of Variation 219
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of Cycles (each cycle is 28 days) 1, 2, 4, 8, 12, and 16; Day 15 of Cycle 3; at atezolizumab treatment discontinuation visit, and <90 days after last atezolizumab infusion (up to approximately 31 months)Population: The safety population included all enrolled participants who received at least one dose of study drug. Number analyzed is the number of participants with data available for analysis.
Participants were considered to be ADA positive if they were missing data at baseline but developed an ADA response following study drug administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 4-fold greater (i.e., ≥0.60-titer units) than the titer of the baseline sample (treatment-enhanced ADA response). Participants were considered to be ADA negative if they were missing data at baseline, had a post-baseline ADA result, and all post-baseline samples were negative, or if they were ADA positive at baseline but did not have any post-baseline samples with a titer that was at least 4-fold greater than the titer of the baseline sample (treatment unaffected).
Outcome measures
| Measure |
Cohort 4 - SCCHN - Previous Treatment Exposure
n=10 Participants
In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 5 - UC - Previous Treatment Exposure
n=1 Participants
In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 6 - RCC - Previous Treatment Exposure
n=2 Participants
In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 1 - SCCHN - Treatment Naive
n=19 Participants
In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 2 - UC - Treatment Naive
n=19 Participants
In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 3 - RCC - Treatment Naive
n=17 Participants
In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Anti-drug Antibodies (ADAs)
|
5 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
10 Participants
|
6 Participants
|
Adverse Events
Cohort 1 - SCCHN - Treatment Naive
Serious events: 13 serious events
Other events: 20 other events
Deaths: 12 deaths
Cohort 2 - UC - Treatment Naive
Serious events: 9 serious events
Other events: 19 other events
Deaths: 12 deaths
Cohort 3 - RCC - Treatment Naive
Serious events: 8 serious events
Other events: 17 other events
Deaths: 8 deaths
Cohort 4 - SCCHN - Previous Treatment Exposure
Serious events: 10 serious events
Other events: 19 other events
Deaths: 12 deaths
Cohort 5 - UC - Previous Treatment Exposure
Serious events: 4 serious events
Other events: 7 other events
Deaths: 6 deaths
Cohort 6 - RCC - Previous Treatment Exposure
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort 1 - SCCHN - Treatment Naive
n=20 participants at risk
In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 2 - UC - Treatment Naive
n=19 participants at risk
In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 3 - RCC - Treatment Naive
n=17 participants at risk
In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 4 - SCCHN - Previous Treatment Exposure
n=20 participants at risk
In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 5 - UC - Previous Treatment Exposure
n=7 participants at risk
In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 6 - RCC - Previous Treatment Exposure
n=3 participants at risk
In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|---|
|
Investigations
EJECTION FRACTION DECREASED
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR HAEMORRHAGE
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Cardiac disorders
PERICARDITIS
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
COLITIS
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
10.0%
2/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
GASTRITIS EROSIVE
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
ILEUS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
LARGE INTESTINAL OBSTRUCTION
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
LARGE INTESTINE PERFORATION
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
PNEUMATOSIS INTESTINALIS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
ASTHENIA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
CHILLS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
FACE OEDEMA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
FATIGUE
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
PYREXIA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
IMMUNE-MEDIATED HEPATITIS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
DEVICE RELATED SEPSIS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
ENDOCARDITIS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
PNEUMONIA
|
15.0%
3/20 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.5%
2/19 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.5%
2/19 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE RESPIRATORY FAILURE
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
ALTERED STATE OF CONSCIOUSNESS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
IMMUNE-MEDIATED ENCEPHALITIS
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Product Issues
DEVICE DISLOCATION
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
NEPHRITIS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY TRACT OEDEMA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
RASH MACULAR
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
GASTROSTOMY
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Cohort 1 - SCCHN - Treatment Naive
n=20 participants at risk
In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 2 - UC - Treatment Naive
n=19 participants at risk
In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 3 - RCC - Treatment Naive
n=17 participants at risk
In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 4 - SCCHN - Previous Treatment Exposure
n=20 participants at risk
In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 5 - UC - Previous Treatment Exposure
n=7 participants at risk
In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
Cohort 6 - RCC - Previous Treatment Exposure
n=3 participants at risk
In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|---|
|
Eye disorders
VITREOUS FLOATERS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Eye disorders
SWELLING OF EYELID
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Eye disorders
TRICHIASIS
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Eye disorders
VISION BLURRED
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Eye disorders
VISUAL IMPAIRMENT
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
40.0%
8/20 • Number of events 9 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
31.6%
6/19 • Number of events 6 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
23.5%
4/17 • Number of events 5 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 4 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
5.0%
1/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
LYMPH NODE PAIN
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
LYMPHADENITIS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
10.0%
2/20 • Number of events 7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
28.6%
2/7 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK FIRST DEGREE
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Cardiac disorders
PERICARDITIS
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Cardiac disorders
VENTRICULAR DYSFUNCTION
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
HYPOACUSIS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
INNER EAR DISORDER
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Endocrine disorders
HYPERTHYROIDISM
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
15.0%
3/20 • Number of events 4 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Endocrine disorders
THYROIDITIS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Eye disorders
CATARACT
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Eye disorders
CHORIORETINOPATHY
|
10.0%
2/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
15.8%
3/19 • Number of events 4 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Eye disorders
ENTROPION
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Eye disorders
EYELID OEDEMA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Eye disorders
EYELID PTOSIS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Eye disorders
GLAUCOMA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Eye disorders
LACRIMATION INCREASED
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Eye disorders
MACULAR OEDEMA
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Eye disorders
OPTIC NERVE DISORDER
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Eye disorders
PERIORBITAL OEDEMA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Eye disorders
RETINAL OEDEMA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Eye disorders
RETINOPATHY
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Eye disorders
SUBRETINAL FLUID
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.5%
2/19 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
28.6%
2/7 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
ANAL HAEMORRHAGE
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
ANGULAR CHEILITIS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
CHEILITIS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
CONSTIPATION
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
26.3%
5/19 • Number of events 7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
17.6%
3/17 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
20.0%
4/20 • Number of events 4 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
DIAPHRAGMATIC HERNIA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
DIARRHOEA
|
35.0%
7/20 • Number of events 9 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
57.9%
11/19 • Number of events 15 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
52.9%
9/17 • Number of events 13 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
65.0%
13/20 • Number of events 16 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
71.4%
5/7 • Number of events 6 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
66.7%
2/3 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
DRY MOUTH
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
10.0%
2/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
21.1%
4/19 • Number of events 4 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
17.6%
3/17 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
10.0%
2/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.5%
2/19 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
15.0%
3/20 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
GINGIVAL BLEEDING
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
GLOSSITIS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
GLOSSODYNIA
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.5%
2/19 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
LIP OEDEMA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
LIP PAIN
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
LIP SWELLING
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
MUCOUS STOOLS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
NAUSEA
|
30.0%
6/20 • Number of events 6 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
15.8%
3/19 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
29.4%
5/17 • Number of events 5 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
30.0%
6/20 • Number of events 8 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
57.1%
4/7 • Number of events 5 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
ORAL DISCHARGE
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
ORAL PAIN
|
5.0%
1/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
STOMATITIS
|
10.0%
2/20 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
26.3%
5/19 • Number of events 5 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
20.0%
4/20 • Number of events 4 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
VOMITING
|
35.0%
7/20 • Number of events 9 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
21.1%
4/19 • Number of events 8 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
17.6%
3/17 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
20.0%
4/20 • Number of events 4 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
ASTHENIA
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
15.8%
3/19 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
CHEST PAIN
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
CHILLS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
28.6%
2/7 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
FACE OEDEMA
|
10.0%
2/20 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.5%
2/19 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
FACIAL PAIN
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
FATIGUE
|
30.0%
6/20 • Number of events 6 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
47.4%
9/19 • Number of events 14 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
29.4%
5/17 • Number of events 7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
25.0%
5/20 • Number of events 5 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
71.4%
5/7 • Number of events 5 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
GENERALISED OEDEMA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
15.8%
3/19 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
LOCALISED OEDEMA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
MALAISE
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
MUCOSAL INFLAMMATION
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
OEDEMA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
OEDEMA PERIPHERAL
|
15.0%
3/20 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.5%
2/19 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
17.6%
3/17 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
28.6%
2/7 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
PAIN
|
15.0%
3/20 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.5%
2/19 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
PERIPHERAL SWELLING
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.5%
2/19 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
PYREXIA
|
10.0%
2/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
36.8%
7/19 • Number of events 9 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
29.4%
5/17 • Number of events 9 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
57.1%
4/7 • Number of events 4 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
SWELLING FACE
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
BRONCHITIS
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
CANDIDA INFECTION
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
CONJUNCTIVITIS
|
10.0%
2/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
CYSTITIS BACTERIAL
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
INFECTION
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
15.0%
3/20 • Number of events 4 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
ORAL HERPES
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
OTITIS EXTERNA
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
OTITIS MEDIA
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
RASH PUSTULAR
|
10.0%
2/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.5%
2/19 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
RHINITIS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
SKIN INFECTION
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
TONGUE FUNGAL INFECTION
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
TOOTH INFECTION
|
5.0%
1/20 • Number of events 4 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
21.1%
4/19 • Number of events 5 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
57.1%
4/7 • Number of events 4 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
URINARY TRACT INFECTION STAPHYLOCOCCAL
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
FACE INJURY
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
FALL
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
15.8%
3/19 • Number of events 4 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
INJURY
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL SWELLING
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
STRESS FRACTURE
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
WOUND COMPLICATION
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.5%
2/19 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
15.8%
3/19 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 4 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
5.0%
1/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
20.0%
4/20 • Number of events 4 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
36.8%
7/19 • Number of events 9 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
17.6%
3/17 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
42.9%
3/7 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Investigations
BLOOD CREATININE INCREASED
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
21.1%
4/19 • Number of events 4 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Investigations
BLOOD MAGNESIUM DECREASED
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Investigations
BLOOD POTASSIUM DECREASED
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Investigations
BLOOD PRESSURE DECREASED
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Investigations
BLOOD PRESSURE INCREASED
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Investigations
BLOOD THYROID STIMULATING HORMONE INCREASED
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Investigations
BLOOD URIC ACID INCREASED
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Investigations
BRAIN NATRIURETIC PEPTIDE INCREASED
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Investigations
CYTOMEGALOVIRUS TEST POSITIVE
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Investigations
EJECTION FRACTION DECREASED
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Investigations
INTERNATIONAL NORMALISED RATIO INCREASED
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Investigations
PLATELET COUNT DECREASED
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Investigations
PLATELET COUNT INCREASED
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Investigations
VITAMIN B12 DECREASED
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Investigations
VITAMIN D DECREASED
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Investigations
WEIGHT DECREASED
|
10.0%
2/20 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
15.8%
3/19 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
20.0%
4/20 • Number of events 5 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
CACHEXIA
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
20.0%
4/20 • Number of events 4 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
36.8%
7/19 • Number of events 8 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
17.6%
3/17 • Number of events 4 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
10.0%
2/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
15.8%
3/19 • Number of events 4 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
35.3%
6/17 • Number of events 7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
10.0%
2/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
10.0%
2/20 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
5.0%
1/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
15.8%
3/19 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.5%
2/19 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
IRON DEFICIENCY
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
10.0%
2/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.5%
2/19 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
17.6%
3/17 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
GROIN PAIN
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
10.0%
2/20 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
10.0%
2/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.5%
2/19 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
MYOSITIS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS OF JAW
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
15.0%
3/20 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.5%
2/19 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
28.6%
2/7 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
SYNOVITIS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
TRISMUS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA OF COLON
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER PAIN
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
KERATOACANTHOMA
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR HAEMORRHAGE
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
APHASIA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
CAUDA EQUINA SYNDROME
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
21.1%
4/19 • Number of events 4 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
DIZZINESS POSTURAL
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
DYSARTHRIA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
28.6%
2/7 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
HEADACHE
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
15.0%
3/20 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
28.6%
2/7 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
LUMBAR RADICULOPATHY
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
PRESYNCOPE
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.5%
2/19 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
RESTLESS LEGS SYNDROME
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
STATUS EPILEPTICUS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
SYNCOPE
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
TASTE DISORDER
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Psychiatric disorders
ANGER
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
10.0%
2/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Psychiatric disorders
DISORIENTATION
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Psychiatric disorders
INSOMNIA
|
15.0%
3/20 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
DYSURIA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.5%
2/19 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
42.9%
3/7 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
15.8%
3/19 • Number of events 4 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
28.6%
2/7 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
NOCTURIA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
POLLAKIURIA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
PROTEINURIA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
URINARY TRACT PAIN
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
SCROTAL OEDEMA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
TESTICULAR SWELLING
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
VAGINAL DISCHARGE
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.5%
2/19 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
21.1%
4/19 • Number of events 5 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
21.1%
4/19 • Number of events 4 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
5.0%
1/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGEAL OEDEMA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL OBSTRUCTION
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
10.0%
2/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
10.0%
2/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
RALES
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
BLISTER
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
15.0%
3/20 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.5%
2/19 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
17.6%
3/17 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
25.0%
5/20 • Number of events 5 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
28.6%
2/7 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS PSORIASIFORM
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
15.0%
3/20 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
20.0%
4/20 • Number of events 5 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
INTERTRIGO
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
ONYCHOCLASIS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
10.0%
2/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
15.8%
3/19 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
20.0%
4/20 • Number of events 4 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
42.9%
3/7 • Number of events 6 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
RASH
|
45.0%
9/20 • Number of events 10 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
47.4%
9/19 • Number of events 11 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
70.6%
12/17 • Number of events 14 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
25.0%
5/20 • Number of events 6 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
71.4%
5/7 • Number of events 7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
RASH PAPULAR
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
SKIN FISSURES
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
STASIS DERMATITIS
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Vascular disorders
FLUSHING
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Vascular disorders
HYPERTENSION
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
15.0%
3/20 • Number of events 8 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Vascular disorders
HYPOTENSION
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Vascular disorders
LYMPHOEDEMA
|
5.0%
1/20 • Number of events 1 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/19 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
5.3%
1/19 • Number of events 2 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/17 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/20 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 31 months
The safety population included all enrolled participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER