Trial Outcomes & Findings for A Study of LY3022855 in Combination With Durvalumab or Tremelimumab in Participants With Advanced Solid Tumors (NCT NCT02718911)
NCT ID: NCT02718911
Last Updated: 2023-10-16
Results Overview
Recommended Phase 2 dose of LY3022855 that could be safely administered in combination with Durvalumab was based on defined dose limiting toxicities (DLT) assessment and MTD definition. MTD is defined as the highest tested dose that has less than 33% probability of causing a DLT.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
72 participants
Primary outcome timeframe
Cycle 1 (4 weeks)
Results posted on
2023-10-16
Participant Flow
This study has two parts: Part A: Dose-escalation of LY3022855 combined with durvalumab or tremelimumab. Part B: Dose-expansion of LY3022855 combined with durvalumab.
Participant milestones
| Measure |
Cohort D1A: LY3022855 (25 mg,QW)+Durvalumab (750mg,Q2W)
25 mg LY3022855 administered once weekly (QW) intravenously (IV) in combination with 750 mg durvalumab administered every 2 weeks (Q2W) IV. Treatment may continue until disease progression or discontinuation.
|
Cohort D2A: LY3022855 (50 mg,QW)+Durvalumab (750mg,Q2W)
50 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort D3A: LY3022855 (75 mg,QW)+Durvalumab (750mg,Q2W)
75 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort D4A: LY3022855 (100 mg,QW)+Durvalumab (750mg,Q2W)
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T1A: LY3022855 (50 mg,QW) +Tremelimumab (75mg,Q4W)
50 mg LY3022855 administered QW intravenously (IV) in combination with 75 mg tremelimumab administered every 4 weeks (Q4W) IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T2A: LY3022855 (100 mg,QW) +Tremelimumab (75mg,Q4W)
100 mg LY3022855 administered QW intravenously (IV) in combination with 75 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T3A: LY3022855 (100 mg,QW) +Tremelimumab (225 mg,Q4W)
100 mg LY3022855 administered QW intravenously (IV) in combination with 225 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T4A: LY3022855 (100 mg,QW) +Tremelimumab (750 mg,Q4W)
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort B-1: NSCLC LY3022855+ Durvalumab
Cohort B-1: NSCLC
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort B-1: OVARIAN LY3022855+ Durvalumab
Cohort B-1: OVARIAN
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
3
|
5
|
3
|
5
|
5
|
5
|
19
|
20
|
|
Overall Study
Received at Least One Dose of Study Drug
|
4
|
3
|
3
|
5
|
3
|
5
|
5
|
5
|
19
|
20
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
4
|
1
|
2
|
2
|
2
|
7
|
1
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
3
|
1
|
2
|
3
|
3
|
3
|
12
|
19
|
Reasons for withdrawal
| Measure |
Cohort D1A: LY3022855 (25 mg,QW)+Durvalumab (750mg,Q2W)
25 mg LY3022855 administered once weekly (QW) intravenously (IV) in combination with 750 mg durvalumab administered every 2 weeks (Q2W) IV. Treatment may continue until disease progression or discontinuation.
|
Cohort D2A: LY3022855 (50 mg,QW)+Durvalumab (750mg,Q2W)
50 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort D3A: LY3022855 (75 mg,QW)+Durvalumab (750mg,Q2W)
75 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort D4A: LY3022855 (100 mg,QW)+Durvalumab (750mg,Q2W)
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T1A: LY3022855 (50 mg,QW) +Tremelimumab (75mg,Q4W)
50 mg LY3022855 administered QW intravenously (IV) in combination with 75 mg tremelimumab administered every 4 weeks (Q4W) IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T2A: LY3022855 (100 mg,QW) +Tremelimumab (75mg,Q4W)
100 mg LY3022855 administered QW intravenously (IV) in combination with 75 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T3A: LY3022855 (100 mg,QW) +Tremelimumab (225 mg,Q4W)
100 mg LY3022855 administered QW intravenously (IV) in combination with 225 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T4A: LY3022855 (100 mg,QW) +Tremelimumab (750 mg,Q4W)
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort B-1: NSCLC LY3022855+ Durvalumab
Cohort B-1: NSCLC
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort B-1: OVARIAN LY3022855+ Durvalumab
Cohort B-1: OVARIAN
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Death
|
2
|
3
|
1
|
0
|
1
|
3
|
1
|
1
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
1
|
1
|
0
|
0
|
0
|
1
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
4
|
|
Overall Study
Reason Not Collected
|
0
|
0
|
1
|
0
|
0
|
0
|
2
|
1
|
4
|
9
|
Baseline Characteristics
A Study of LY3022855 in Combination With Durvalumab or Tremelimumab in Participants With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Cohort D1A: LY3022855 (25 mg,QW)+Durvalumab (750mg,Q2W)
n=4 Participants
25 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort D2A: LY3022855 (50 mg,QW)+Durvalumab (750mg,Q2W)
n=3 Participants
50 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort D3A: LY3022855 (75 mg,QW)+Durvalumab (750mg,Q2W)
n=3 Participants
75 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort D4A: LY3022855 (100 mg,QW)+Durvalumab (750mg,Q2W)
n=5 Participants
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T1A: LY3022855 (50 mg,QW) +Tremelimumab (75mg,Q4W)
n=3 Participants
50 mg LY3022855 administered QW intravenously (IV) in combination with 75 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T2A: LY3022855 (100 mg,QW) +Tremelimumab (75mg,Q4W)
n=5 Participants
100 mg LY3022855 administered QW intravenously (IV) in combination with 75 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T3A: LY3022855 (100 mg,QW) +Tremelimumab (225 mg,Q4W)
n=5 Participants
100 mg LY3022855 administered QW intravenously (IV) in combination with 225 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T4A: LY3022855 (100 mg,QW) +Tremelimumab (750 mg,Q4W)
n=5 Participants
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort B-1: NSCLC LY3022855+ Durvalumab
n=19 Participants
Cohort B-1: NSCLC
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort B-1: OVARIAN LY3022855+ Durvalumab
n=20 Participants
Cohort B-1: OVARIAN
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
65.8 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
68.7 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
59.0 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
56.8 years
STANDARD_DEVIATION 6.4 • n=4 Participants
|
59.3 years
STANDARD_DEVIATION 7.1 • n=21 Participants
|
55.2 years
STANDARD_DEVIATION 20.1 • n=10 Participants
|
62.4 years
STANDARD_DEVIATION 11.7 • n=115 Participants
|
60.6 years
STANDARD_DEVIATION 9.6 • n=24 Participants
|
62.5 years
STANDARD_DEVIATION 8.5 • n=42 Participants
|
55.8 years
STANDARD_DEVIATION 15.0 • n=42 Participants
|
59.7 years
STANDARD_DEVIATION 11.9 • n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
20 Participants
n=42 Participants
|
45 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
27 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
19 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
66 Participants
n=42 Participants
|
|
Ethnicity (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
|
1 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 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
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
19 Participants
n=42 Participants
|
20 Participants
n=42 Participants
|
66 Participants
n=42 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
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 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
|
2 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
Region of Enrollment
Belgium
|
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
|
0 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
|
Region of Enrollment
Czechia
|
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
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Region of Enrollment
Israel
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
33 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (4 weeks)Population: All participants who received at least one dose of study drug LY3022855 + Durvalumab.
Recommended Phase 2 dose of LY3022855 that could be safely administered in combination with Durvalumab was based on defined dose limiting toxicities (DLT) assessment and MTD definition. MTD is defined as the highest tested dose that has less than 33% probability of causing a DLT.
Outcome measures
| Measure |
LY3022855 + Durvalumab
n=15 Participants
Cohort D1A: 25 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV.
Cohort D2A: 50 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV.
Cohort D3A: 75 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV.
Cohort D4A: 100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV.
Treatment may continue until disease progression or discontinuation.
|
Cohort D2A: LY3022855 (50 mg,QW)+Durvalumab (750mg,Q2W)
50 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort D3A: LY3022855 (75 mg,QW)+Durvalumab (750mg,Q2W)
75 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort D4A: LY3022855 (100 mg,QW)+Durvalumab (750mg,Q2W)
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T1A: LY3022855 (50 mg,QW) +Tremelimumab (75mg,Q4W)
50 mg LY3022855 administered QW intravenously (IV) in combination with 75 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T2A: LY3022855 (100 mg,QW) +Tremelimumab (75mg,Q4W)
100 mg LY3022855 administered QW intravenously (IV) in combination with 75 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T3A: LY3022855 (100 mg,QW) +Tremelimumab (225 mg,Q4W)
100 mg LY3022855 administered QW intravenously (IV) in combination with 225 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T4A: LY3022855 (100 mg,QW) +Tremelimumab (750 mg,Q4W)
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort B-1: NSCLC LY3022855+ Durvalumab
Cohort B-1: NSCLC
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort B-1: OVARIAN LY3022855+ Durvalumab
Cohort B-1: OVARIAN
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Recommended Phase 2 Dose of LY3022855 Combined With Durvalumab (Maximum Tolerated Dose [MTD])
|
100 milligrams (mg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through Measured Progressive Disease or Death (Up To 24 months)Population: All participants who received at least one dose of study drug.
ORR was estimated as the percentage of participants with best response of Complete Response (CR) or Partial Response (PR), based on RECIST version 1.1 divided by the total number of participants. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. Progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Outcome measures
| Measure |
LY3022855 + Durvalumab
n=4 Participants
Cohort D1A: 25 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV.
Cohort D2A: 50 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV.
Cohort D3A: 75 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV.
Cohort D4A: 100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV.
Treatment may continue until disease progression or discontinuation.
|
Cohort D2A: LY3022855 (50 mg,QW)+Durvalumab (750mg,Q2W)
n=3 Participants
50 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort D3A: LY3022855 (75 mg,QW)+Durvalumab (750mg,Q2W)
n=3 Participants
75 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort D4A: LY3022855 (100 mg,QW)+Durvalumab (750mg,Q2W)
n=5 Participants
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T1A: LY3022855 (50 mg,QW) +Tremelimumab (75mg,Q4W)
n=3 Participants
50 mg LY3022855 administered QW intravenously (IV) in combination with 75 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T2A: LY3022855 (100 mg,QW) +Tremelimumab (75mg,Q4W)
n=5 Participants
100 mg LY3022855 administered QW intravenously (IV) in combination with 75 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T3A: LY3022855 (100 mg,QW) +Tremelimumab (225 mg,Q4W)
n=5 Participants
100 mg LY3022855 administered QW intravenously (IV) in combination with 225 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T4A: LY3022855 (100 mg,QW) +Tremelimumab (750 mg,Q4W)
n=5 Participants
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort B-1: NSCLC LY3022855+ Durvalumab
n=19 Participants
Cohort B-1: NSCLC
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort B-1: OVARIAN LY3022855+ Durvalumab
n=20 Participants
Cohort B-1: OVARIAN
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Exhibit Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
40.0 Percentage of participants
Interval 7.6 to 81.1
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
5.0 Percentage of participants
Interval 0.3 to 21.6
|
SECONDARY outcome
Timeframe: Baseline through Measured Progressive Disease (Up To 24 months)Population: All participants who received at least one dose of study drug.
DCR is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Outcome measures
| Measure |
LY3022855 + Durvalumab
n=4 Participants
Cohort D1A: 25 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV.
Cohort D2A: 50 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV.
Cohort D3A: 75 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV.
Cohort D4A: 100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV.
Treatment may continue until disease progression or discontinuation.
|
Cohort D2A: LY3022855 (50 mg,QW)+Durvalumab (750mg,Q2W)
n=3 Participants
50 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort D3A: LY3022855 (75 mg,QW)+Durvalumab (750mg,Q2W)
n=3 Participants
75 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort D4A: LY3022855 (100 mg,QW)+Durvalumab (750mg,Q2W)
n=5 Participants
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T1A: LY3022855 (50 mg,QW) +Tremelimumab (75mg,Q4W)
n=3 Participants
50 mg LY3022855 administered QW intravenously (IV) in combination with 75 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T2A: LY3022855 (100 mg,QW) +Tremelimumab (75mg,Q4W)
n=5 Participants
100 mg LY3022855 administered QW intravenously (IV) in combination with 75 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T3A: LY3022855 (100 mg,QW) +Tremelimumab (225 mg,Q4W)
n=5 Participants
100 mg LY3022855 administered QW intravenously (IV) in combination with 225 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T4A: LY3022855 (100 mg,QW) +Tremelimumab (750 mg,Q4W)
n=5 Participants
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort B-1: NSCLC LY3022855+ Durvalumab
n=19 Participants
Cohort B-1: NSCLC
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort B-1: OVARIAN LY3022855+ Durvalumab
n=20 Participants
Cohort B-1: OVARIAN
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)]
|
75.0 Percentage of participants
Interval 24.9 to 98.7
|
33.3 Percentage of participants
Interval 1.7 to 86.5
|
66.7 Percentage of participants
Interval 13.5 to 98.3
|
80.0 Percentage of participants
Interval 34.3 to 99.0
|
33.3 Percentage of participants
Interval 1.7 to 86.5
|
20.0 Percentage of participants
Interval 1.0 to 65.7
|
20.0 Percentage of participants
Interval 1.0 to 65.7
|
40.0 Percentage of participants
Interval 7.6 to 81.1
|
21.1 Percentage of participants
Interval 7.5 to 41.9
|
25.0 Percentage of participants
Interval 10.4 to 45.6
|
SECONDARY outcome
Timeframe: Baseline through Follow-up (Up To 24 Months)Population: All participants who received at least one dose of study drug.
Number of participants with positive Anti-LY3022855, Anti-Durvalumab or Anti-Tremelimumab Antibodies was summarized by cohorts.
Outcome measures
| Measure |
LY3022855 + Durvalumab
n=4 Participants
Cohort D1A: 25 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV.
Cohort D2A: 50 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV.
Cohort D3A: 75 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV.
Cohort D4A: 100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV.
Treatment may continue until disease progression or discontinuation.
|
Cohort D2A: LY3022855 (50 mg,QW)+Durvalumab (750mg,Q2W)
n=3 Participants
50 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort D3A: LY3022855 (75 mg,QW)+Durvalumab (750mg,Q2W)
n=3 Participants
75 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort D4A: LY3022855 (100 mg,QW)+Durvalumab (750mg,Q2W)
n=5 Participants
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T1A: LY3022855 (50 mg,QW) +Tremelimumab (75mg,Q4W)
n=3 Participants
50 mg LY3022855 administered QW intravenously (IV) in combination with 75 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T2A: LY3022855 (100 mg,QW) +Tremelimumab (75mg,Q4W)
n=5 Participants
100 mg LY3022855 administered QW intravenously (IV) in combination with 75 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T3A: LY3022855 (100 mg,QW) +Tremelimumab (225 mg,Q4W)
n=5 Participants
100 mg LY3022855 administered QW intravenously (IV) in combination with 225 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T4A: LY3022855 (100 mg,QW) +Tremelimumab (750 mg,Q4W)
n=5 Participants
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort B-1: NSCLC LY3022855+ Durvalumab
n=19 Participants
Cohort B-1: NSCLC
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort B-1: OVARIAN LY3022855+ Durvalumab
n=20 Participants
Cohort B-1: OVARIAN
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Anti-LY3022855, Anti-Durvalumab or Anti-Tremelimumab Antibodies
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: 2 hours post End of Infusion (EOI), Day 2: 24-hour post EOI, Day 3: 48 hour post EOI; Cycle 2 Day 8: 2 h post-EOI, Day 9: 24 h post-EOI, Day 10: 48 h post-EOIPopulation: All participants who received at least one dose of study drug and had evaluable PK data. Cohort B-1 NSCLC and Cohort B-1 OVARIAN data were combined because they are escalating cohort and the participants are received the same dose.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3022855 in Combination with either Durvalumab or Tremelimumab, and the Single-Dose
Outcome measures
| Measure |
LY3022855 + Durvalumab
n=4 Participants
Cohort D1A: 25 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV.
Cohort D2A: 50 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV.
Cohort D3A: 75 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV.
Cohort D4A: 100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV.
Treatment may continue until disease progression or discontinuation.
|
Cohort D2A: LY3022855 (50 mg,QW)+Durvalumab (750mg,Q2W)
n=3 Participants
50 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort D3A: LY3022855 (75 mg,QW)+Durvalumab (750mg,Q2W)
n=3 Participants
75 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort D4A: LY3022855 (100 mg,QW)+Durvalumab (750mg,Q2W)
n=44 Participants
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T1A: LY3022855 (50 mg,QW) +Tremelimumab (75mg,Q4W)
n=3 Participants
50 mg LY3022855 administered QW intravenously (IV) in combination with 75 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T2A: LY3022855 (100 mg,QW) +Tremelimumab (75mg,Q4W)
n=5 Participants
100 mg LY3022855 administered QW intravenously (IV) in combination with 75 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T3A: LY3022855 (100 mg,QW) +Tremelimumab (225 mg,Q4W)
n=5 Participants
100 mg LY3022855 administered QW intravenously (IV) in combination with 225 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T4A: LY3022855 (100 mg,QW) +Tremelimumab (750 mg,Q4W)
n=5 Participants
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort B-1: NSCLC LY3022855+ Durvalumab
Cohort B-1: NSCLC
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort B-1: OVARIAN LY3022855+ Durvalumab
Cohort B-1: OVARIAN
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3022855 in Combination With Either Durvalumab or Tremelimumab, and the Single-Dose
Cycle 1
|
5.33 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 46
|
11.9 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 72
|
23.8 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 22
|
32.9 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 28
|
13.8 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 30
|
32 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 30
|
30.3 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 25
|
27 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 34
|
—
|
—
|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3022855 in Combination With Either Durvalumab or Tremelimumab, and the Single-Dose
Cycle 2:
|
5.11 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 61
|
16.6 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 8
|
35.3 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 17
|
43.1 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 38
|
15.1 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 33
|
44.4 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 39
|
—
|
30.7 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 16
|
—
|
—
|
Adverse Events
Cohort D1A: LY3022855 (25 mg,QW)+Durvalumab (750mg,Q2W)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 2 deaths
Cohort D2A: LY3022855 (50 mg,QW)+Durvalumab (750mg,Q2W)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort D3A: LY3022855 (75 mg,QW)+Durvalumab (750mg,Q2W)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Cohort D4A: LY3022855 (100 mg,QW)+Durvalumab (750mg,Q2W)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort T1A: LY3022855 (50 mg,QW) +Tremelimumab (75mg,Q4W)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Cohort T2A: LY3022855 (100 mg,QW) +Tremelimumab (75mg,Q4W)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 3 deaths
Cohort T3A: LY3022855 (100 mg,QW) +Tremelimumab (225 mg,Q4W)
Serious events: 3 serious events
Other events: 5 other events
Deaths: 1 deaths
Cohort T4A: LY3022855 (100 mg,QW) +Tremelimumab (750 mg,Q4W)
Serious events: 3 serious events
Other events: 5 other events
Deaths: 1 deaths
Cohort B-1: NSCLC LY3022855+ Durvalumab
Serious events: 12 serious events
Other events: 19 other events
Deaths: 4 deaths
Cohort B-1: OVARIAN LY3022855+ Durvalumab
Serious events: 5 serious events
Other events: 20 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Cohort D1A: LY3022855 (25 mg,QW)+Durvalumab (750mg,Q2W)
n=4 participants at risk
25 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort D2A: LY3022855 (50 mg,QW)+Durvalumab (750mg,Q2W)
n=3 participants at risk
50 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort D3A: LY3022855 (75 mg,QW)+Durvalumab (750mg,Q2W)
n=3 participants at risk
75 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort D4A: LY3022855 (100 mg,QW)+Durvalumab (750mg,Q2W)
n=5 participants at risk
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T1A: LY3022855 (50 mg,QW) +Tremelimumab (75mg,Q4W)
n=3 participants at risk
50 mg LY3022855 administered QW intravenously (IV) in combination with 75 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T2A: LY3022855 (100 mg,QW) +Tremelimumab (75mg,Q4W)
n=5 participants at risk
100 mg LY3022855 administered QW intravenously (IV) in combination with 75 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T3A: LY3022855 (100 mg,QW) +Tremelimumab (225 mg,Q4W)
n=5 participants at risk
100 mg LY3022855 administered QW intravenously (IV) in combination with 225 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T4A: LY3022855 (100 mg,QW) +Tremelimumab (750 mg,Q4W)
n=5 participants at risk
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort B-1: NSCLC LY3022855+ Durvalumab
n=19 participants at risk
Cohort B-1: NSCLC
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort B-1: OVARIAN LY3022855+ Durvalumab
n=20 participants at risk
Cohort B-1: OVARIAN
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Investigations
Amylase increased
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
General disorders
Generalised oedema
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Infections and infestations
Septic shock
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Product Issues
Device occlusion
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
Other adverse events
| Measure |
Cohort D1A: LY3022855 (25 mg,QW)+Durvalumab (750mg,Q2W)
n=4 participants at risk
25 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort D2A: LY3022855 (50 mg,QW)+Durvalumab (750mg,Q2W)
n=3 participants at risk
50 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort D3A: LY3022855 (75 mg,QW)+Durvalumab (750mg,Q2W)
n=3 participants at risk
75 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort D4A: LY3022855 (100 mg,QW)+Durvalumab (750mg,Q2W)
n=5 participants at risk
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T1A: LY3022855 (50 mg,QW) +Tremelimumab (75mg,Q4W)
n=3 participants at risk
50 mg LY3022855 administered QW intravenously (IV) in combination with 75 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T2A: LY3022855 (100 mg,QW) +Tremelimumab (75mg,Q4W)
n=5 participants at risk
100 mg LY3022855 administered QW intravenously (IV) in combination with 75 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T3A: LY3022855 (100 mg,QW) +Tremelimumab (225 mg,Q4W)
n=5 participants at risk
100 mg LY3022855 administered QW intravenously (IV) in combination with 225 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort T4A: LY3022855 (100 mg,QW) +Tremelimumab (750 mg,Q4W)
n=5 participants at risk
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort B-1: NSCLC LY3022855+ Durvalumab
n=19 participants at risk
Cohort B-1: NSCLC
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
Cohort B-1: OVARIAN LY3022855+ Durvalumab
n=20 participants at risk
Cohort B-1: OVARIAN
100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Diverticulitis
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
15.8%
3/19 • Number of events 5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
15.8%
3/19 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Nervous system disorders
Balance disorder
|
25.0%
1/4 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Nervous system disorders
Burning sensation
|
25.0%
1/4 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.5%
2/19 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Nervous system disorders
Drooling
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
21.1%
4/19 • Number of events 5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
25.0%
5/20 • Number of events 13 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Nervous system disorders
Neuropathy peripheral
|
25.0%
1/4 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Renal and urinary disorders
Chromaturia
|
25.0%
1/4 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Renal and urinary disorders
Dysuria
|
25.0%
1/4 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Renal and urinary disorders
Haematuria
|
25.0%
1/4 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.5%
2/19 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Breast swelling
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Coital bleeding
|
100.0%
1/1 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/8 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
100.0%
3/3 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
66.7%
2/3 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
66.7%
2/3 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
15.8%
3/19 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
66.7%
2/3 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
26.3%
5/19 • Number of events 5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
4/20 • Number of events 6 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.5%
2/19 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
1/4 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
1/4 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary venous thrombosis
|
25.0%
1/4 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.0%
1/4 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Hair growth rate abnormal
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 6 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
100.0%
3/3 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
60.0%
3/5 • Number of events 9 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
60.0%
3/5 • Number of events 5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 8 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.5%
2/19 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
15.0%
3/20 • Number of events 6 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
1/4 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 11 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
60.0%
3/5 • Number of events 6 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
15.0%
3/20 • Number of events 9 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.5%
2/19 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
15.8%
3/19 • Number of events 10 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
35.0%
7/20 • Number of events 9 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
66.7%
2/3 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
15.8%
3/19 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.0%
2/20 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
60.0%
3/5 • Number of events 5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
31.6%
6/19 • Number of events 16 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
30.0%
6/20 • Number of events 14 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Cardiac disorders
Atrial enlargement
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac discomfort
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
15.0%
3/20 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Eye disorders
Diplopia
|
25.0%
1/4 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Eye disorders
Eye swelling
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
15.8%
3/19 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Eye disorders
Meibomianitis
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
21.1%
4/19 • Number of events 5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
30.0%
6/20 • Number of events 8 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
25.0%
1/4 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal distension
|
25.0%
1/4 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.5%
2/19 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
15.0%
3/20 • Number of events 5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.5%
2/19 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
4/20 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
25.0%
1/4 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.0%
2/20 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Anorectal swelling
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
15.0%
3/20 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
15.8%
3/19 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
15.0%
3/20 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
60.0%
3/5 • Number of events 5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
26.3%
5/19 • Number of events 7 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
4/20 • Number of events 5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
4/20 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.5%
2/19 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
66.7%
2/3 • Number of events 5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
60.0%
3/5 • Number of events 6 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
36.8%
7/19 • Number of events 12 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
45.0%
9/20 • Number of events 15 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
66.7%
2/3 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
26.3%
5/19 • Number of events 6 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
4/20 • Number of events 8 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
General disorders
Administration site coldness
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
General disorders
Asthenia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.5%
2/19 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
General disorders
Catheter site inflammation
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
General disorders
Catheter site pain
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
General disorders
Catheter site scab
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
General disorders
Chills
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
15.8%
3/19 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
General disorders
Early satiety
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
General disorders
Face oedema
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
60.0%
3/5 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
21.1%
4/19 • Number of events 6 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
25.0%
5/20 • Number of events 5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
General disorders
Fatigue
|
75.0%
3/4 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
100.0%
3/3 • Number of events 5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
100.0%
3/3 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
60.0%
3/5 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
60.0%
3/5 • Number of events 5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
42.1%
8/19 • Number of events 11 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
55.0%
11/20 • Number of events 18 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
General disorders
Feeling cold
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
60.0%
3/5 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
General disorders
Localised oedema
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
General disorders
Malaise
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
General disorders
Nodule
|
25.0%
1/4 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.5%
2/19 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
60.0%
3/5 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
15.8%
3/19 • Number of events 6 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
25.0%
5/20 • Number of events 6 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
General disorders
Pain
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
General disorders
Peripheral swelling
|
25.0%
1/4 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
25.0%
1/4 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
21.1%
4/19 • Number of events 6 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
4/20 • Number of events 5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Hepatobiliary disorders
Jaundice
|
25.0%
1/4 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Investigations
Blood potassium increased
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Infections and infestations
Device related infection
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Infections and infestations
Influenza
|
25.0%
1/4 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Infections and infestations
Oesophageal infection
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
25.0%
1/4 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.0%
2/20 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Infections and infestations
Wound infection
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fall
|
25.0%
1/4 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 6 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
21.1%
4/19 • Number of events 5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
35.0%
7/20 • Number of events 14 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Investigations
Amylase increased
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.5%
2/19 • Number of events 6 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
4/20 • Number of events 6 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 7 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
36.8%
7/19 • Number of events 13 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
50.0%
10/20 • Number of events 30 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Investigations
Aspiration pleural cavity
|
25.0%
1/4 • Number of events 10 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
21.1%
4/19 • Number of events 7 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Investigations
Blood bilirubin increased
|
25.0%
1/4 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.5%
2/19 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Investigations
Blood creatine increased
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
66.7%
2/3 • Number of events 6 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
60.0%
3/5 • Number of events 22 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
60.0%
3/5 • Number of events 18 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 6 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
60.0%
3/5 • Number of events 7 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
31.6%
6/19 • Number of events 15 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
45.0%
9/20 • Number of events 22 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.5%
2/19 • Number of events 6 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.0%
2/20 • Number of events 6 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.5%
2/19 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Investigations
Blood urea increased
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Investigations
Electrocardiogram repolarisation abnormality
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.0%
2/20 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Investigations
Lipase increased
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
15.0%
3/20 • Number of events 5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 12 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Investigations
Qrs axis abnormal
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
15.8%
3/19 • Number of events 5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Investigations
Weight increased
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
2/4 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
60.0%
3/5 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
52.6%
10/19 • Number of events 11 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
30.0%
6/20 • Number of events 6 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.0%
2/20 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.5%
2/19 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.5%
2/19 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
15.8%
3/19 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.0%
2/20 • Number of events 5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.5%
2/19 • Number of events 12 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 6 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
21.1%
4/19 • Number of events 9 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.5%
2/19 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
15.0%
3/20 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
25.0%
1/4 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.0%
2/20 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
100.0%
3/3 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
21.1%
4/19 • Number of events 4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
15.0%
3/20 • Number of events 5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.5%
2/19 • Number of events 6 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
10.0%
2/20 • Number of events 3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
25.0%
1/4 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/4 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/3 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/5 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/19 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
0.00%
0/20 • Up To 30 Months
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60