Trial Outcomes & Findings for Study of ASTX029 in Subjects With Advanced Solid Tumors (NCT NCT03520075)
NCT ID: NCT03520075
Last Updated: 2025-07-03
Results Overview
DLTs were defined as adverse events (AEs) graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 criteria that occurred during the first cycle of treatment and represented any 1 of the following: grade 4 thrombocytopenia of any duration; ≥grade 3 hematologic toxicity with complications (e.g., grade 3 thrombocytopenia with bleeding or transfusion requirement); febrile neutropenia of any duration or grade 4 neutropenia of 5 days or more duration; liver-associated abnormalities; ≥grade 2 eye disorders; symptomatic grade 2 cutaneous toxicities (including skin rash); any other ≥grade 3 nonhematologic AE except grade 3 nausea, vomiting, or diarrhea; Any event that, in the opinion of the Data and Safety Review Committee (DSRC), would suggest that further dose escalation would put subjects at unacceptable risk.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
192 participants
Primary outcome timeframe
Cycle 1 (cycle length = 21 days)
Results posted on
2025-07-03
Participant Flow
Participants took part at regional sites in United States (US), France, Spain, and United Kingdom (UK) from 07 May 2018 to 03 March 2025.
A total of 192 participants were enrolled in the study to receive ASTX029, of which 2 participants died before receiving treatment. The study was conducted in 2 phases: Phase 1 included Cohorts 1-12 in Part A (Dose Escalation) and a single cohort for Part B (Dose Expansion) and Phase 2 included Cohorts A to F.
Participant milestones
| Measure |
Phase 1A: Cohort 1 Dose Escalation
Participants received ASTX029 10 milligrams (mg), powder in bottle (PiB), orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 3 Dose Escalation
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 2: Cohort A
Participants with neuroblastoma RAS (NRAS)-mutant melanoma received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
Phase 2: Cohort B
Participants with Kirsten RAS (KRAS)-mutant or KRAS-amplified non-small cell lung cancer (NSCLC) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
Phase 2: Cohort C
Participants with B isoform of RAF kinase (BRAF) V600-mutant cancers (non-colorectal cancers) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
Phase 2: Cohort D
Participants with BRAF-fusion cancers received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
Phase 2: Cohort E
Participants with gynecological cancers with alterations in the mitogen-activated protein kinase (MAPK) pathway received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
Phase 2: Cohort F
Participants with tumors that were characterized by other gene aberrations (that upregulate the MAPK signal pathway) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 (Dose Escalation)
STARTED
|
3
|
3
|
3
|
5
|
10
|
7
|
3
|
3
|
3
|
3
|
7
|
7
|
20
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 (Dose Escalation)
Safety Analysis Set Included All Participants Who Received Any Amount of Study Drug.
|
3
|
3
|
3
|
5
|
10
|
6
|
3
|
3
|
3
|
3
|
7
|
7
|
20
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 (Dose Escalation)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 (Dose Escalation)
NOT COMPLETED
|
3
|
3
|
3
|
5
|
10
|
7
|
3
|
3
|
3
|
3
|
6
|
7
|
19
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2 (Dose Expansion)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
32
|
15
|
12
|
9
|
32
|
15
|
|
Phase 2 (Dose Expansion)
Safety Analysis Set Included All Participants Who Received Any Amount of Study Drug.
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
32
|
15
|
12
|
9
|
32
|
14
|
|
Phase 2 (Dose Expansion)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
5
|
0
|
|
Phase 2 (Dose Expansion)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
26
|
15
|
12
|
9
|
27
|
15
|
Reasons for withdrawal
| Measure |
Phase 1A: Cohort 1 Dose Escalation
Participants received ASTX029 10 milligrams (mg), powder in bottle (PiB), orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 3 Dose Escalation
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 2: Cohort A
Participants with neuroblastoma RAS (NRAS)-mutant melanoma received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
Phase 2: Cohort B
Participants with Kirsten RAS (KRAS)-mutant or KRAS-amplified non-small cell lung cancer (NSCLC) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
Phase 2: Cohort C
Participants with B isoform of RAF kinase (BRAF) V600-mutant cancers (non-colorectal cancers) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
Phase 2: Cohort D
Participants with BRAF-fusion cancers received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
Phase 2: Cohort E
Participants with gynecological cancers with alterations in the mitogen-activated protein kinase (MAPK) pathway received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
Phase 2: Cohort F
Participants with tumors that were characterized by other gene aberrations (that upregulate the MAPK signal pathway) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 (Dose Escalation)
Death
|
2
|
2
|
3
|
2
|
6
|
5
|
3
|
2
|
3
|
1
|
5
|
7
|
11
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 (Dose Escalation)
Complete Consent Withdrawal
|
1
|
0
|
0
|
2
|
3
|
2
|
0
|
1
|
0
|
1
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 (Dose Escalation)
Lost to Follow-up
|
0
|
1
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 (Dose Escalation)
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2 (Dose Expansion)
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
20
|
13
|
9
|
5
|
14
|
12
|
|
Phase 2 (Dose Expansion)
Complete Consent Withdrawal
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
1
|
3
|
2
|
|
Phase 2 (Dose Expansion)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
1
|
|
Phase 2 (Dose Expansion)
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
3
|
10
|
0
|
Baseline Characteristics
Study of ASTX029 in Subjects With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=3 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=3 Participants
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 3 Dose Escalation
n=3 Participants
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=5 Participants
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
n=10 Participants
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
n=6 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
n=3 Participants
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
n=3 Participants
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
n=3 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
n=3 Participants
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
n=7 Participants
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
n=7 Participants
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1B Dose Expansion
n=20 Participants
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 2: Cohort A
n=32 Participants
Participants with NRAS-mutant melanoma received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
Phase 2: Cohort B
n=15 Participants
Participants with KRAS-mutant or KRAS-amplified NSCLC received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
Phase 2: Cohort C
n=12 Participants
Participants with BRAF V600-mutant cancers (non-colorectal cancers) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
Phase 2: Cohort D
n=9 Participants
Participants with BRAF-fusion cancers received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
Phase 2: Cohort E
n=32 Participants
Participants with gynecological cancers with alterations in the MAPK pathway received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
Phase 2: Cohort F
n=14 Participants
Participants with tumors that were characterized by other gene aberrations (that upregulate the MAPK signal pathway) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
Total
n=190 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
18 - 64
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
11 Participants
n=36 Participants
|
14 Participants
n=36 Participants
|
5 Participants
n=24 Participants
|
7 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
16 Participants
n=44 Participants
|
7 Participants
n=667 Participants
|
96 Participants
n=12 Participants
|
|
Age, Customized
65 - 84
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
8 Participants
n=36 Participants
|
18 Participants
n=36 Participants
|
9 Participants
n=24 Participants
|
5 Participants
n=135 Participants
|
6 Participants
n=136 Participants
|
16 Participants
n=44 Participants
|
7 Participants
n=667 Participants
|
92 Participants
n=12 Participants
|
|
Age, Customized
>=85
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
2 Participants
n=12 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
12 Participants
n=36 Participants
|
12 Participants
n=36 Participants
|
10 Participants
n=24 Participants
|
7 Participants
n=135 Participants
|
5 Participants
n=136 Participants
|
32 Participants
n=44 Participants
|
6 Participants
n=667 Participants
|
121 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
8 Participants
n=36 Participants
|
20 Participants
n=36 Participants
|
5 Participants
n=24 Participants
|
5 Participants
n=135 Participants
|
4 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
8 Participants
n=667 Participants
|
69 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Hispanic, Latino/a, or Spanish origin
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
4 Participants
n=44 Participants
|
2 Participants
n=667 Participants
|
22 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Not of Hispanic, Latino/a, or Spanish origin
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
19 Participants
n=36 Participants
|
30 Participants
n=36 Participants
|
12 Participants
n=24 Participants
|
8 Participants
n=135 Participants
|
8 Participants
n=136 Participants
|
25 Participants
n=44 Participants
|
12 Participants
n=667 Participants
|
164 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
3 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
4 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Asian
|
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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
6 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
8 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian and Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
16 Participants
n=36 Participants
|
20 Participants
n=36 Participants
|
12 Participants
n=24 Participants
|
7 Participants
n=135 Participants
|
6 Participants
n=136 Participants
|
27 Participants
n=44 Participants
|
11 Participants
n=667 Participants
|
145 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
4 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
10 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
4 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
21 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
1 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
5 Participants
n=12 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (cycle length = 21 days)Population: The safety analysis set included data from all participants who received any amount of study drug.
DLTs were defined as adverse events (AEs) graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 criteria that occurred during the first cycle of treatment and represented any 1 of the following: grade 4 thrombocytopenia of any duration; ≥grade 3 hematologic toxicity with complications (e.g., grade 3 thrombocytopenia with bleeding or transfusion requirement); febrile neutropenia of any duration or grade 4 neutropenia of 5 days or more duration; liver-associated abnormalities; ≥grade 2 eye disorders; symptomatic grade 2 cutaneous toxicities (including skin rash); any other ≥grade 3 nonhematologic AE except grade 3 nausea, vomiting, or diarrhea; Any event that, in the opinion of the Data and Safety Review Committee (DSRC), would suggest that further dose escalation would put subjects at unacceptable risk.
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=3 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=3 Participants
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
n=20 Participants
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
n=3 Participants
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=5 Participants
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
n=10 Participants
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
n=6 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
n=3 Participants
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
n=3 Participants
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
n=3 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
n=3 Participants
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
n=7 Participants
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
n=7 Participants
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 30 days after last dose (Up to 74 months)Population: The safety analysis set included data from all participants who received any amount of study drug.
An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. TEAEs are defined as events that first occurred or worsened on or after the date of the first dose of study treatment until 30 days after the last dose of study treatment or until the start of a posttreatment alternative anti-cancer treatment, whichever occurs first, with the following exceptions: events that occurred after 30 days beyond the last dose of study treatment or the start of a posttreatment alternative anti-cancer treatment will also be considered treatment-emergent if the events are both serious and related to the study treatment.
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=3 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=3 Participants
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
n=20 Participants
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
n=3 Participants
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=5 Participants
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
n=10 Participants
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
n=6 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
n=3 Participants
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
n=3 Participants
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
n=3 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
n=3 Participants
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
n=7 Participants
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
n=7 Participants
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
3 Participants
|
3 Participants
|
20 Participants
|
3 Participants
|
5 Participants
|
10 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
7 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Every 2 cycles for the first 4 cycles and then every 4 cycles thereafter until disease progression (Up to 74 months)Population: The efficacy analysis set included all participants who received any amount of study drug. The ORR analysis was based on participants who were in the efficacy analysis set and who had disease assessment at baseline and at least 1 follow-up disease assessment or participants who died or stopped treatment before the first scheduled disease assessment due to clinical progression or toxicity.
The ORR was calculated as the number of evaluable participants whose best response was complete response (CR) or partial response (PR), divided by the total number of participants evaluable for ORR analysis. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Percentages were rounded off to the nearest single decimal place
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=32 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=15 Participants
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
n=12 Participants
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=9 Participants
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
n=32 Participants
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
n=14 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
|
12.5 percentage of participants
Interval 4.4 to 26.4
|
0 percentage of participants
Interval 0.0 to 18.1
|
—
|
8.3 percentage of participants
Interval 0.4 to 33.9
|
0 percentage of participants
Interval 0.0 to 28.3
|
12.5 percentage of participants
Interval 4.4 to 26.4
|
7.1 percentage of participants
Interval 0.4 to 29.7
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)Population: The pharmacokinetics (PK) analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint.
As per planned analysis, data for participants from Part A (Dose Escalation) and Part B (Expansion) were combined for Cohort 11 (200 mg). 2 participants who received 200 and 280 mg respectively, in Cycle 1 Day1 (C1D1), received 120 mg in Cycle 2 and Day 1 (C2D1) and hence counted in Cohort 10. 1 participant who received 280 mg in C1D1, received 200 mg in C2D1 and hence counted in Cohort 11.
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=3 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=3 Participants
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
n=3 Participants
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=5 Participants
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
n=10 Participants
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
n=6 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
n=3 Participants
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
n=2 Participants
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
n=3 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
n=5 Participants
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
n=26 Participants
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
n=7 Participants
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) of ASTX029
Cycle 1 Day 1 (C1D1)
|
277 hours*nanograms/milliliters (h*ng/mL)
Geometric Coefficient of Variation 20.1
|
361 hours*nanograms/milliliters (h*ng/mL)
Geometric Coefficient of Variation 222.0
|
—
|
1150 hours*nanograms/milliliters (h*ng/mL)
Geometric Coefficient of Variation 10.0
|
4020 hours*nanograms/milliliters (h*ng/mL)
Geometric Coefficient of Variation 83.0
|
7250 hours*nanograms/milliliters (h*ng/mL)
Geometric Coefficient of Variation 63.7
|
1810 hours*nanograms/milliliters (h*ng/mL)
Geometric Coefficient of Variation 126.9
|
3360 hours*nanograms/milliliters (h*ng/mL)
Geometric Coefficient of Variation 140.4
|
3080 hours*nanograms/milliliters (h*ng/mL)
Geometric Coefficient of Variation 128.2
|
6500 hours*nanograms/milliliters (h*ng/mL)
Geometric Coefficient of Variation 64.3
|
5710 hours*nanograms/milliliters (h*ng/mL)
Geometric Coefficient of Variation 27.1
|
13400 hours*nanograms/milliliters (h*ng/mL)
Geometric Coefficient of Variation 46.4
|
17800 hours*nanograms/milliliters (h*ng/mL)
Geometric Coefficient of Variation 83.6
|
|
Phase 1: Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) of ASTX029
Cycle 2 Day 1 (C2D1)
|
339 hours*nanograms/milliliters (h*ng/mL)
Geometric Coefficient of Variation 58.4
|
618 hours*nanograms/milliliters (h*ng/mL)
Geometric Coefficient of Variation 11.7
|
—
|
1410 hours*nanograms/milliliters (h*ng/mL)
Geometric Coefficient of Variation 61.4
|
3530 hours*nanograms/milliliters (h*ng/mL)
Geometric Coefficient of Variation 104.5
|
7550 hours*nanograms/milliliters (h*ng/mL)
Geometric Coefficient of Variation 76.9
|
2490 hours*nanograms/milliliters (h*ng/mL)
Geometric Coefficient of Variation 108.4
|
3710 hours*nanograms/milliliters (h*ng/mL)
Geometric Coefficient of Variation 106.0
|
3370 hours*nanograms/milliliters (h*ng/mL)
Geometric Coefficient of Variation 117.8
|
6430 hours*nanograms/milliliters (h*ng/mL)
Geometric Coefficient of Variation 71.6
|
7850 hours*nanograms/milliliters (h*ng/mL)
Geometric Coefficient of Variation 37.1
|
15400 hours*nanograms/milliliters (h*ng/mL)
Geometric Coefficient of Variation 57.5
|
25600 hours*nanograms/milliliters (h*ng/mL)
Geometric Coefficient of Variation 91.9
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)Population: The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint.
As per planned analysis, data for participants from Part A (Dose Escalation) and Part B (Expansion) were combined for Cohort 11 (200 mg). 2 participants who received 200 and 280 mg respectively, in C1D1 received 120 mg in C2D1 and hence counted in Cohort 10. 1 participant who received 280 mg in C1D1, received 200 mg in C2D1 and hence counted in Cohort 11.
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=3 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=3 Participants
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
n=3 Participants
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=5 Participants
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
n=10 Participants
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
n=6 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
n=3 Participants
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
n=3 Participants
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
n=3 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
n=5 Participants
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
n=27 Participants
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
n=7 Participants
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ASTX029
C1D1
|
262 h*ng/mL
Geometric Coefficient of Variation 18.5
|
347 h*ng/mL
Geometric Coefficient of Variation 215.6
|
—
|
1140 h*ng/mL
Geometric Coefficient of Variation 10.0
|
4020 h*ng/mL
Geometric Coefficient of Variation 82.9
|
7250 h*ng/mL
Geometric Coefficient of Variation 63.7
|
1740 h*ng/mL
Geometric Coefficient of Variation 137.5
|
3360 h*ng/mL
Geometric Coefficient of Variation 140.4
|
1620 h*ng/mL
Geometric Coefficient of Variation 215.6
|
6450 h*ng/mL
Geometric Coefficient of Variation 65.8
|
5710 h*ng/mL
Geometric Coefficient of Variation 26.9
|
12800 h*ng/mL
Geometric Coefficient of Variation 51.2
|
17800 h*ng/mL
Geometric Coefficient of Variation 83.6
|
|
Phase 1: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ASTX029
C2D1
|
321 h*ng/mL
Geometric Coefficient of Variation 56.1
|
298 h*ng/mL
Geometric Coefficient of Variation 177.3
|
—
|
1410 h*ng/mL
Geometric Coefficient of Variation 61.5
|
3530 h*ng/mL
Geometric Coefficient of Variation 104.5
|
7530 h*ng/mL
Geometric Coefficient of Variation 77.2
|
2430 h*ng/mL
Geometric Coefficient of Variation 116.3
|
3660 h*ng/mL
Geometric Coefficient of Variation 104.2
|
3340 h*ng/mL
Geometric Coefficient of Variation 116.4
|
6450 h*ng/mL
Geometric Coefficient of Variation 72.0
|
7850 h*ng/mL
Geometric Coefficient of Variation 37.1
|
13500 h*ng/mL
Geometric Coefficient of Variation 80.0
|
25300 h*ng/mL
Geometric Coefficient of Variation 93.7
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)Population: The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint.
As per planned analysis, data for participants from Part A (Dose Escalation) and Part B (Expansion) were combined for Cohort 11 (200 mg). 2 participants who received 200 and 280 mg respectively, in C1D1, received 120 mg in C2D1 and hence counted in Cohort 10. 1 participant who received 280 mg in C1D1, received 200 mg in C2D1 and hence counted in Cohort 11.
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=3 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=3 Participants
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
n=3 Participants
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=5 Participants
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
n=9 Participants
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
n=4 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
n=3 Participants
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
n=2 Participants
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
n=3 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
n=5 Participants
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
n=25 Participants
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
n=7 Participants
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of ASTX029
C1D1
|
327 h*ng/mL
Geometric Coefficient of Variation 3.6
|
358 h*ng/mL
Geometric Coefficient of Variation 209.2
|
—
|
1150 h*ng/mL
Geometric Coefficient of Variation 14.1
|
4050 h*ng/mL
Geometric Coefficient of Variation 82.5
|
8170 h*ng/mL
Geometric Coefficient of Variation 53.5
|
1180 h*ng/mL
Geometric Coefficient of Variation 112.9
|
3390 h*ng/mL
Geometric Coefficient of Variation 139.3
|
3120 h*ng/mL
Geometric Coefficient of Variation 126.3
|
6520 h*ng/mL
Geometric Coefficient of Variation 66.6
|
5770 h*ng/mL
Geometric Coefficient of Variation 26.7
|
13500 h*ng/mL
Geometric Coefficient of Variation 47.1
|
17900 h*ng/mL
Geometric Coefficient of Variation 83.1
|
|
Phase 1: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of ASTX029
C2D1
|
346 h*ng/mL
Geometric Coefficient of Variation 52.9
|
243 h*ng/mL
Geometric Coefficient of Variation 228.9
|
—
|
1430 h*ng/mL
Geometric Coefficient of Variation 60.9
|
5160 h*ng/mL
Geometric Coefficient of Variation 55.0
|
7670 h*ng/mL
Geometric Coefficient of Variation 75.3
|
2470 h*ng/mL
Geometric Coefficient of Variation 116.1
|
3190 h*ng/mL
Geometric Coefficient of Variation 169.8
|
3420 h*ng/mL
Geometric Coefficient of Variation 113.6
|
5590 h*ng/mL
Geometric Coefficient of Variation 101.3
|
7930 h*ng/mL
Geometric Coefficient of Variation 37.2
|
15700 h*ng/mL
Geometric Coefficient of Variation 59.0
|
25600 h*ng/mL
Geometric Coefficient of Variation 92.2
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)Population: The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint.
As per planned analysis, data for participants from Part A (Dose Escalation) and Part B (Expansion) were combined for Cohort 11 (200 mg). 2 participants who received 200 and 280 mg respectively, in C1D1, received 120 mg in C2D1 and hence counted in Cohort 10. 1 participant who received 280 mg in C1D1, received 200 mg in C2D1 and hence counted in Cohort 11.
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=3 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=3 Participants
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
n=3 Participants
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=5 Participants
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
n=10 Participants
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
n=6 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
n=3 Participants
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
n=3 Participants
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
n=3 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
n=5 Participants
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
n=27 Participants
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
n=7 Participants
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Maximum Observed Plasma Concentration (Cmax) of ASTX029
C1D1
|
109 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 48.5
|
217 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 165.4
|
—
|
469 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 9.5
|
1650 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 56.8
|
1850 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 66.7
|
496 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 127.7
|
1490 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 141.7
|
742 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 301.5
|
2840 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 30.8
|
2060 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 49.5
|
5240 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 61.0
|
6040 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 58.4
|
|
Phase 1: Maximum Observed Plasma Concentration (Cmax) of ASTX029
C2D1
|
143 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 177.8
|
107 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 119.2
|
—
|
598 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 111.0
|
903 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 228.8
|
1830 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 177.6
|
641 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 91.4
|
1710 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 124.4
|
2330 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 130.8
|
1860 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 55.8
|
2360 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 40.9
|
5350 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 78.7
|
8070 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 50.7
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycle 2 (Cycle length = 21 days)Population: The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. Overall number of participants analyzed is the number of participants with data available for analysis.
As per planned analysis, data for participants from Part A (Dose Escalation) and Part B (Expansion) were combined for Cohort 11 (200 mg). 2 participants who received 200 and 280 mg respectively, in C1D1, received 120 mg in C2D1 and hence counted in Cohort 10. 1 participant who received 280 mg in C1D1, received 200 mg in C2D1 and hence counted in Cohort 11. Data for Cmin was calculated and analyzed for C2D1 only.
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=3 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=3 Participants
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
n=3 Participants
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=4 Participants
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
n=5 Participants
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
n=4 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
n=3 Participants
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
n=2 Participants
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
n=3 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
n=5 Participants
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
n=25 Participants
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
n=3 Participants
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Minimum Plasma Concentration (Cmin) of ASTX029
|
4.38 ng/mL
Geometric Coefficient of Variation 86.7
|
1.45 ng/mL
Geometric Coefficient of Variation 173.2
|
—
|
23.4 ng/mL
Geometric Coefficient of Variation 127.8
|
19.3 ng/mL
Geometric Coefficient of Variation 149.7
|
18.1 ng/mL
Geometric Coefficient of Variation 39.7
|
7.88 ng/mL
Geometric Coefficient of Variation 79.3
|
68.1 ng/mL
Geometric Coefficient of Variation 128.8
|
8.68 ng/mL
Geometric Coefficient of Variation 64.0
|
20.1 ng/mL
Geometric Coefficient of Variation 114.7
|
85.3 ng/mL
Geometric Coefficient of Variation 206.9
|
188 ng/mL
Geometric Coefficient of Variation 194.3
|
168 ng/mL
Geometric Coefficient of Variation 85.6
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)Population: The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint.
As per planned analysis, data for participants from Part A (Dose Escalation) and Part B (Expansion) were combined for Cohort 11 (200 mg). 2 participants who received 200 and 280 mg respectively, in C1D1, received 120 mg in C2D1 and hence counted in Cohort 10. 1 participant who received 280 mg in C1D1, received 200 mg in C2D1 and hence counted in Cohort 11.
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=3 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=3 Participants
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
n=3 Participants
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=5 Participants
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
n=10 Participants
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
n=6 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
n=3 Participants
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
n=3 Participants
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
n=3 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
n=5 Participants
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
n=27 Participants
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
n=7 Participants
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Time to Reach Maximum Concentration (Tmax) of ASTX029
C1D1
|
1.08 hours
Interval 0.57 to 3.05
|
0.50 hours
Interval 0.5 to 0.58
|
—
|
0.55 hours
Interval 0.47 to 0.97
|
0.50 hours
Interval 0.5 to 1.0
|
0.71 hours
Interval 0.43 to 4.08
|
3.03 hours
Interval 1.08 to 5.73
|
1.00 hours
Interval 0.98 to 3.0
|
1.07 hours
Interval 1.0 to 4.02
|
1.00 hours
Interval 0.47 to 1.88
|
1.88 hours
Interval 0.53 to 1.93
|
1.97 hours
Interval 0.5 to 6.0
|
2.03 hours
Interval 1.0 to 4.0
|
|
Phase 1: Time to Reach Maximum Concentration (Tmax) of ASTX029
C2D1
|
0.53 hours
Interval 0.5 to 2.2
|
1.00 hours
Interval 0.55 to 1.05
|
—
|
0.50 hours
Interval 0.47 to 0.92
|
2.52 hours
Interval 0.92 to 5.7
|
0.55 hours
Interval 0.5 to 1.0
|
2.48 hours
Interval 0.52 to 3.85
|
1.02 hours
Interval 0.5 to 7.53
|
1.52 hours
Interval 1.0 to 2.03
|
3.00 hours
Interval 2.93 to 5.67
|
2.1 hours
Interval 1.08 to 4.0
|
2.02 hours
Interval 0.92 to 7.52
|
1.90 hours
Interval 0.55 to 3.85
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)Population: The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint.
As per planned analysis, data for participants from Part A (Dose Escalation) and Part B (Expansion) were combined for Cohort 11 (200 mg). 2 participants who received 200 and 280 mg respectively, in C1D1, received 120 mg in C2D1 and hence counted in Cohort 10. 1 participant who received 280 mg in C1D1, received 200 mg in C2D1 and hence counted in Cohort 11.
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=3 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=3 Participants
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
n=3 Participants
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=5 Participants
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
n=9 Participants
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
n=4 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
n=3 Participants
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
n=2 Participants
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
n=3 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
n=5 Participants
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
n=25 Participants
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
n=7 Participants
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Elimination Half-Life (T1/2) of ASTX029
C1D1
|
2.42 hours
Geometric Coefficient of Variation 42.1
|
1.63 hours
Geometric Coefficient of Variation 18.7
|
—
|
4.42 hours
Geometric Coefficient of Variation 1.8
|
3.75 hours
Geometric Coefficient of Variation 26.9
|
3.84 hours
Geometric Coefficient of Variation 21.8
|
2.08 hours
Geometric Coefficient of Variation 102.4
|
4.28 hours
Geometric Coefficient of Variation 11.6
|
5.68 hours
Geometric Coefficient of Variation 31.7
|
3.30 hours
Geometric Coefficient of Variation 74.7
|
4.00 hours
Geometric Coefficient of Variation 13.6
|
3.92 hours
Geometric Coefficient of Variation 40.9
|
3.71 hours
Geometric Coefficient of Variation 32.9
|
|
Phase 1: Elimination Half-Life (T1/2) of ASTX029
C2D1
|
3.37 hours
Geometric Coefficient of Variation 119.7
|
1.85 hours
Geometric Coefficient of Variation 64.8
|
—
|
4.98 hours
Geometric Coefficient of Variation 31.5
|
3.61 hours
Geometric Coefficient of Variation 13.5
|
4.11 hours
Geometric Coefficient of Variation 15.9
|
2.58 hours
Geometric Coefficient of Variation 95.1
|
1.01 hours
Geometric Coefficient of Variation 11.6
|
3.13 hours
Geometric Coefficient of Variation 276.4
|
4.67 hours
Geometric Coefficient of Variation 24.1
|
3.88 hours
Geometric Coefficient of Variation 25.6
|
3.80 hours
Geometric Coefficient of Variation 47.2
|
1.28 hours
Geometric Coefficient of Variation 72.1
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)Population: The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. The data is reported here for the arm groups of 80 mg and 120 mg, in both fed and fasted to compare food effect. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint.
The food effect was to be analyzed only for tablet dosage forms. The participants who were administered 80 mg and 120 mg tablets, under both fed and fasted conditions were reported. As 200 mg dose was administered, as tablets, only under fasted conditions, hence food effect was not assessed for 200 mg dose. The statistical comparison between fed and fasted state treatment arm groups of 80 mg and 120 mg doses is reported in this outcome measure for food effect. The 2 participants who received 200 and 280 mg respectively, in C1D1, received 120 mg in C2D1 and hence counted in Cohort 10.
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=6 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=3 Participants
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
n=3 Participants
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=5 Participants
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Effect of Food on AUC0-24 of ASTX029
C2D1
|
2490 h*ng/mL
Geometric Coefficient of Variation 108.4
|
3710 h*ng/mL
Geometric Coefficient of Variation 106.0
|
—
|
6430 h*ng/mL
Geometric Coefficient of Variation 71.6
|
7850 h*ng/mL
Geometric Coefficient of Variation 37.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1: Effect of Food on AUC0-24 of ASTX029
C1D1
|
1810 h*ng/mL
Geometric Coefficient of Variation 126.9
|
3360 h*ng/mL
Geometric Coefficient of Variation 140.4
|
—
|
6500 h*ng/mL
Geometric Coefficient of Variation 64.3
|
5710 h*ng/mL
Geometric Coefficient of Variation 27.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)Population: The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. The data is reported here for the arm groups of 80 mg and 120 mg, in both fed and fasted to compare food effect. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint.
The food effect was to be analyzed only for tablet dosage forms. The participants who were administered 80 mg and 120 mg tablets, under both fed and fasted conditions were reported. As 200 mg dose was administered, as tablets, only under fasted conditions, hence food effect was not assessed for 200 mg dose. The statistical comparison between fed and fasted state treatment arm groups of 80 mg and 120 mg doses is reported in this outcome measure for food effect. The 2 participants who received 200 and 280 mg respectively, in C1D1, received 120 mg in C2D1 and hence counted in Cohort 10.
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=4 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=3 Participants
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
n=3 Participants
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=5 Participants
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Effect of Food on AUC0-inf of ASTX029
C1D1
|
1180 h*ng/mL
Geometric Coefficient of Variation 112.9
|
3390 h*ng/mL
Geometric Coefficient of Variation 139.3
|
—
|
6520 h*ng/mL
Geometric Coefficient of Variation 66.6
|
5770 h*ng/mL
Geometric Coefficient of Variation 26.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1: Effect of Food on AUC0-inf of ASTX029
C2D1
|
2470 h*ng/mL
Geometric Coefficient of Variation 116.1
|
3190 h*ng/mL
Geometric Coefficient of Variation 169.8
|
—
|
5590 h*ng/mL
Geometric Coefficient of Variation 101.3
|
7930 h*ng/mL
Geometric Coefficient of Variation 37.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)Population: The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. The data is reported here for the arm groups of 80 mg and 120 mg, in both fed and fasted to compare food effect. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint.
The food effect was to be analyzed only for tablet dosage forms. The participants who were administered 80 mg and 120 mg tablets, under both fed and fasted conditions were reported. As 200 mg dose was administered, as tablets, only under fasted conditions, hence food effect was not assessed for 200 mg dose. The statistical comparison between fed and fasted state treatment arm groups of 80 mg and 120 mg doses is reported in this outcome measure for food effect. The 2 participants who received 200 and 280 mg respectively, in C1D1, received 120 mg in C2D1 and hence counted in Cohort 10.
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=6 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=3 Participants
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
n=3 Participants
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=5 Participants
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Effect of Food on Cmax of ASTX029
C1D1
|
496 ng/mL
Geometric Coefficient of Variation 127.7
|
1490 ng/mL
Geometric Coefficient of Variation 141.7
|
—
|
2840 ng/mL
Geometric Coefficient of Variation 30.8
|
2060 ng/mL
Geometric Coefficient of Variation 49.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1: Effect of Food on Cmax of ASTX029
C2D1
|
641 ng/mL
Geometric Coefficient of Variation 91.4
|
1710 ng/mL
Geometric Coefficient of Variation 124.4
|
—
|
1860 ng/mL
Geometric Coefficient of Variation 55.8
|
2360 ng/mL
Geometric Coefficient of Variation 40.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)Population: The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. The data is reported here for the arm groups of 80 mg and 120 mg, in both fed and fasted to compare food effect. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint.
The food effect was to be analyzed only for tablet dosage forms. The participants who were administered 80 mg and 120 mg tablets, under both fed and fasted conditions were reported. As 200 mg dose was administered, as tablets, only under fasted conditions, hence food effect was not assessed for 200 mg dose. The statistical comparison between fed and fasted state treatment arm groups of 80 mg and 120 mg doses is reported in this outcome measure for food effect. The 2 participants who received 200 and 280 mg respectively, in C1D1, received 120 mg in C2D1 and hence counted in Cohort 10.
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=6 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=3 Participants
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
n=3 Participants
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=5 Participants
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Effect of Food on Tmax of ASTX029
C1D1
|
3.03 hours
Interval 1.08 to 5.73
|
1.00 hours
Interval 0.98 to 3.0
|
—
|
1.00 hours
Interval 0.47 to 1.88
|
1.88 hours
Interval 0.53 to 1.93
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1: Effect of Food on Tmax of ASTX029
C2D1
|
2.48 hours
Interval 0.52 to 3.85
|
1.02 hours
Interval 0.5 to 7.53
|
—
|
3.00 hours
Interval 2.93 to 5.67
|
2.1 hours
Interval 1.08 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 hours post-dose on Day 8 of Cycle 2 (Cycle length = 21 days)Population: Pharmacodynamics analysis set included in the pharmacodynamic and biomarker analyses if they have received study drug and their samples were successfully collected and analyzed. Overall number of participants analyzed is the number of participants with data available for analysis. The data for this outcome measure was collected and analyzed for Phase 1B Dose Expansion cohort only.
The protein expression level is quantified through the H-score, calculated from staining intensity within the target cell region. H-Score = (3x % of cells with staining graded 3) + (2x % of cells with staining graded 2) + % of cells with staining graded 1. H-Score ranges between 0 to 300. The H-score is for sum of cytoplasmic H-Score (C pRSK H-Score) and nuclear H-Scores (N pRSK H-Score). C pRSK H-Scores, and nuclear H-Scores were combined to give a single H-score.
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=8 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Inhibition of Phosphorylated Ribosomal S6 Kinase (pRSK) Protein in Response to ASTX029 Treatment in Tumor Biopsies as Assessed by H Score
|
181.6 score on a scale
Standard Deviation 172.31
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 2 cycles for the first 4 cycles and then every 4 cycles thereafter until disease progression (Up to 82 months)Population: The efficacy analysis set included all participants who received any amount of study drug.
The PFS was defined as the number of months from the start of the study treatment to disease progression or death, whichever occurs first. The PFS was analyzed using a Kaplan-Meier method, with PFS time being censored on the date of the last disease assessment. The 90% CI for median PFS was provided using the Kaplan-Meier procedure.
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=3 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=3 Participants
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
n=20 Participants
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
n=3 Participants
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=5 Participants
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
n=10 Participants
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
n=6 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
n=3 Participants
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
n=3 Participants
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
n=3 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
n=3 Participants
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
n=7 Participants
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
n=7 Participants
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Progression Free Survival (PFS)
|
1.3 months
Interval 1.2 to
Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
|
1.2 months
Interval 1.2 to
Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
|
1.4 months
Interval 1.2 to 4.2
|
8.1 months
Interval 2.7 to
Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
|
2.0 months
Interval 1.1 to
Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
|
1.2 months
Interval 0.2 to 4.8
|
1.3 months
Interval 0.9 to
Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
|
3.0 months
Interval 1.2 to
Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
|
1.1 months
Interval 1.0 to
Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
|
1.3 months
Interval 1.0 to
Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
|
2.3 months
Interval 1.4 to
Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
|
3.0 months
Interval 0.7 to
Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
|
2.5 months
Interval 0.4 to 4.0
|
SECONDARY outcome
Timeframe: Up to 82 monthsPopulation: The efficacy analysis set included all participants who received any amount of study drug.
The OS was defined as the number of months from the day the participant was randomized to the date of death (regardless of cause). Participants without a documented death date were censored on the last date they were known to be alive. The OS was presented using a Kaplan-Meier estimate. The 90% CI for median OS was provided using the Kaplan-Meier procedure.
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=3 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=3 Participants
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
n=20 Participants
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
n=3 Participants
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=5 Participants
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
n=10 Participants
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
n=6 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
n=3 Participants
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
n=3 Participants
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
n=3 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
n=3 Participants
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
n=7 Participants
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
n=7 Participants
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Overall Survival (OS)
|
13.5 months
Interval 4.4 to
Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
|
4.5 months
Interval 3.4 to
Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
|
15.1 months
Interval 2.7 to 26.3
|
10.2 months
Interval 4.1 to
Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
|
3.8 months
Interval 2.1 to
Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
|
2.1 months
Interval 0.5 to 25.5
|
11.3 months
Interval 4.8 to
Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
|
8.7 months
Interval 2.6 to
Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
|
2.0 months
Interval 1.1 to
Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
|
10.9 months
Interval 1.3 to
Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
|
NA months
Median was not reached. The lower limit and upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
|
14.8 months
Interval 2.7 to
Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
|
2.5 months
Interval 1.2 to 13.1
|
SECONDARY outcome
Timeframe: Every 2 cycles for the first 4 cycles and then every 4 cycles thereafter until disease progression (Up to 82 months)Population: The efficacy analysis set included all participants who received any amount of study drug. The DCR analysis was based on participants who were in the efficacy analysis set and who had disease assessment at baseline and at least 1 follow-up disease assessment or participants who died or stopped treatment before the first scheduled disease assessment due to clinical progression or toxicity.
DCR was calculated as the number of participants whose best response was CR, PR, or stable disease (SD), divided by the total number of participants evaluable for DCR analysis. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm. PR was defined as at least a 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Percentages were rounded off to the nearest single decimal place.
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=3 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=3 Participants
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
n=20 Participants
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
n=3 Participants
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=5 Participants
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
n=10 Participants
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
n=6 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
n=3 Participants
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
n=3 Participants
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
n=3 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
n=3 Participants
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
n=7 Participants
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
n=7 Participants
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Disease Control Rate (DCR)
|
0 percentage of participants
Interval 0.0 to 63.2
|
0 percentage of participants
Interval 0.0 to 63.2
|
30.0 percentage of participants
Interval 14.0 to 50.8
|
100 percentage of participants
Interval 36.8 to 100.0
|
40.0 percentage of participants
Interval 7.6 to 81.1
|
20.0 percentage of participants
Interval 3.7 to 50.7
|
16.7 percentage of participants
Interval 0.9 to 58.2
|
66.7 percentage of participants
Interval 13.5 to 98.3
|
33.3 percentage of participants
Interval 1.7 to 86.5
|
33.3 percentage of participants
Interval 1.7 to 86.5
|
33.3 percentage of participants
Interval 1.7 to 86.5
|
85.7 percentage of participants
Interval 47.9 to 99.3
|
42.9 percentage of participants
Interval 12.9 to 77.5
|
SECONDARY outcome
Timeframe: Every 2 cycles for the first 4 cycles and then every 4 cycles thereafter until disease progression (Up to 82 months)Population: The efficacy analysis set included all participants who received any amount of study drug. Overall number of participants analyzed is the number of participants with data available for analysis.
Duration of response was calculated for all responders from the date of the earliest assessment of CR or PR to the date of relapse or death, whichever occurred earlier, or the last disease assessment date for participants without a relapse or death. Duration of SD was calculated for participants whose best response is CR, PR, or SD from the day study drug was first taken to the date of disease progression or death, whichever occurred earlier, or the last disease assessment for participants without disease progression or death.
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
n=2 Participants
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
n=1 Participants
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
n=1 Participants
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Duration of Response (DoR)
|
—
|
—
|
252.50 days
Interval 252.0 to 253.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
484.0 days
Interval 484.0 to 484.0
|
61.0 days
Interval 61.0 to 61.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 1, and 3; at 0.5,1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycle 1, and at 0.5,1, 2, 4, and 8 hours post-dose on Day 1 of Cycle 3 (Cycle length = 21 days)Population: The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint.
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=24 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=13 Participants
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
n=9 Participants
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=9 Participants
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
n=28 Participants
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
n=12 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: AUC0-24 of ASTX029
C1D1
|
12200 h*ng/mL
Geometric Coefficient of Variation 69.1
|
13000 h*ng/mL
Geometric Coefficient of Variation 57.2
|
—
|
9570 h*ng/mL
Geometric Coefficient of Variation 80.3
|
8730 h*ng/mL
Geometric Coefficient of Variation 100.0
|
12000 h*ng/mL
Geometric Coefficient of Variation 83.3
|
13400 h*ng/mL
Geometric Coefficient of Variation 71.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: AUC0-24 of ASTX029
Cycle 3 Day 1 (C3D1)
|
11600 h*ng/mL
Geometric Coefficient of Variation 76.1
|
27600 h*ng/mL
Geometric Coefficient of Variation 47.3
|
—
|
11500 h*ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimable due to low number of participants at specified time point.
|
12800 h*ng/mL
Geometric Coefficient of Variation 36.2
|
12300 h*ng/mL
Geometric Coefficient of Variation 88.7
|
15300 h*ng/mL
Geometric Coefficient of Variation 52.4
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 1, and 3; at 0.5,1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycle 1, and at 0.5,1, 2, 4, and 8 hours post-dose on Day 1 of Cycle 3 (Cycle length = 21 days)Population: The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint.
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=32 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=15 Participants
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
n=12 Participants
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=9 Participants
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
n=32 Participants
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
n=14 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: AUC0-last of ASTX029
C1D1
|
12300 h*ng/mL
Geometric Coefficient of Variation 70.4
|
15000 h*ng/mL
Geometric Coefficient of Variation 68.5
|
—
|
7800 h*ng/mL
Geometric Coefficient of Variation 81.7
|
8730 h*ng/mL
Geometric Coefficient of Variation 100.0
|
11500 h*ng/mL
Geometric Coefficient of Variation 80.3
|
12700 h*ng/mL
Geometric Coefficient of Variation 66.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: AUC0-last of ASTX029
C3D1
|
8090 h*ng/mL
Geometric Coefficient of Variation 214.2
|
13600 h*ng/mL
Geometric Coefficient of Variation 114.5
|
—
|
1960 h*ng/mL
Geometric Coefficient of Variation 369.9
|
11700 h*ng/mL
Geometric Coefficient of Variation 31.5
|
10400 h*ng/mL
Geometric Coefficient of Variation 86.4
|
14000 h*ng/mL
Geometric Coefficient of Variation 52.1
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycle 1; and at 0.5,1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycle 1 (Cycle length = 21 days)Population: The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. Overall number of participants analyzed is the number of participants with data available for analysis.
Data for Auc0-inf was collected and analyzed for C1D1 only.
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=28 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=13 Participants
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
n=6 Participants
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=7 Participants
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
n=30 Participants
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
n=13 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: AUC0-inf of ASTX029
|
12500 h*ng/mL
Geometric Coefficient of Variation 66.6
|
17100 h*ng/mL
Geometric Coefficient of Variation 60.4
|
—
|
10700 h*ng/mL
Geometric Coefficient of Variation 103.0
|
11800 h*ng/mL
Geometric Coefficient of Variation 62.5
|
12500 h*ng/mL
Geometric Coefficient of Variation 74.5
|
13300 h*ng/mL
Geometric Coefficient of Variation 67.5
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 1, and 3; at 0.5,1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycle 1, and at 0.5,1, 2, 4, and 8 hours post-dose on Day 1 of Cycle 3 (Cycle length = 21 days)Population: The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint.
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=32 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=15 Participants
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
n=12 Participants
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=9 Participants
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
n=32 Participants
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
n=14 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Cmax of ASTX029
C1D1
|
4430 ng/mL
Geometric Coefficient of Variation 70.9
|
5930 ng/mL
Geometric Coefficient of Variation 81.3
|
—
|
2890 ng/mL
Geometric Coefficient of Variation 97.7
|
2840 ng/mL
Geometric Coefficient of Variation 239.4
|
4660 ng/mL
Geometric Coefficient of Variation 113.6
|
5620 ng/mL
Geometric Coefficient of Variation 65.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Cmax of ASTX029
C3D1
|
3280 ng/mL
Geometric Coefficient of Variation 179.3
|
4730 ng/mL
Geometric Coefficient of Variation 150.7
|
—
|
780 ng/mL
Geometric Coefficient of Variation 464.1
|
5090 ng/mL
Geometric Coefficient of Variation 43.5
|
4410 ng/mL
Geometric Coefficient of Variation 110.4
|
4860 ng/mL
Geometric Coefficient of Variation 66.8
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycle 3; and at 0.5,1, 2, 4, and 8 post-dose on Day 1 of Cycle 3 (Cycle length = 21 days)Population: The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. Overall number of participants analyzed is the number of participants with data available for analysis.
Data for Cmin was calculated and analyzed for C3D1 only.
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=19 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=7 Participants
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
n=5 Participants
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=5 Participants
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
n=20 Participants
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
n=5 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Cmin of ASTX029
|
189 ng/mL
Geometric Coefficient of Variation 181.0
|
260 ng/mL
Geometric Coefficient of Variation 95.5
|
—
|
81.7 ng/mL
Geometric Coefficient of Variation 102.0
|
144 ng/mL
Geometric Coefficient of Variation 78.2
|
205 ng/mL
Geometric Coefficient of Variation 104.9
|
246 ng/mL
Geometric Coefficient of Variation 67.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 1, and 3; at 0.5,1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycle 1, and at 0.5,1, 2, 4, and 8 hours post-dose on Day 1 of Cycle 3 (Cycle length = 21 days)Population: The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint.
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=32 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=15 Participants
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
n=12 Participants
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=9 Participants
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
n=32 Participants
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
n=14 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Tmax of ASTX029
C1D1
|
2.03 hours
Interval 0.5 to 4.08
|
1.95 hours
Interval 0.95 to 6.08
|
—
|
2.90 hours
Interval 0.5 to 7.55
|
2.07 hours
Interval 0.92 to 7.9
|
2.00 hours
Interval 0.4 to 4.07
|
2.00 hours
Interval 1.0 to 3.87
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Tmax of ASTX029
C3D1
|
2.00 hours
Interval 0.97 to 4.05
|
2.03 hours
Interval 0.58 to 4.05
|
—
|
2.03 hours
Interval 0.67 to 7.53
|
1.90 hours
Interval 1.0 to 2.0
|
2.00 hours
Interval 0.48 to 4.17
|
1.97 hours
Interval 0.95 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycle 1; at 0.5,1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycle 1 (Cycle length = 21 days)Population: The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. Overall number of participants analyzed is the number of participants with data available for analysis.
Data for T1/2 was collected and analyzed for C1D1 only.
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=28 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=13 Participants
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
n=6 Participants
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=7 Participants
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
n=30 Participants
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
n=13 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: T1/2 of ASTX029
|
2.68 hours
Geometric Coefficient of Variation 68.8
|
3.45 hours
Geometric Coefficient of Variation 52.0
|
—
|
3.79 hours
Geometric Coefficient of Variation 19.1
|
3.73 hours
Geometric Coefficient of Variation 12.2
|
3.64 hours
Geometric Coefficient of Variation 43.2
|
3.39 hours
Geometric Coefficient of Variation 48.2
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 2 cycles for the first 4 cycles and then every 4 cycles thereafter until disease progression (Up to 82 months)Population: The efficacy analysis set included all participants who received any amount of study drug.
The PFS was defined as the number of months from the start of the study treatment to disease progression or death, whichever occurs first. The PFS was analyzed using a Kaplan-Meier method, with PFS time being censored on the date of the last disease assessment. The 90% CI for median PFS was provided using the Kaplan-Meier procedure.
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=32 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=15 Participants
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
n=12 Participants
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=9 Participants
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
n=32 Participants
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
n=14 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Progression Free Survival
|
2.8 months
Interval 1.5 to 5.5
|
2.8 months
Interval 0.9 to 4.6
|
—
|
1.7 months
Interval 0.8 to 6.1
|
8.0 months
Interval 1.0 to 9.6
|
3.5 months
Interval 2.2 to 6.2
|
2.0 months
Interval 1.2 to 5.5
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 82 monthsPopulation: The efficacy analysis set included all participants who received any amount of study drug.
The OS was defined as the number of months from the day the participant was randomized to the date of death (regardless of cause). Participants without a documented death date were censored on the last date they were known to be alive. The OS was presented using a KM estimate. The 90% CI for median OS was provided using the Kaplan-Meier procedure.
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=32 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=15 Participants
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
n=12 Participants
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=9 Participants
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
n=32 Participants
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
n=14 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Overall Survival
|
8.0 months
Interval 4.4 to 13.6
|
4.9 months
Interval 1.5 to 10.1
|
—
|
6.1 months
Interval 1.1 to 19.3
|
11.6 months
Interval 2.0 to
Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
|
11.2 months
Interval 6.8 to
Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
|
9.9 months
Interval 3.5 to 15.9
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 2 cycles for the first 4 cycles and then every 4 cycles thereafter until disease progression (Up to 82 months)Population: The efficacy analysis set included all participants who received any amount of study drug. The DCR analysis was based on participants who were in the efficacy analysis set and who had disease assessment at baseline and at least 1 follow-up disease assessment or participants who died or stopped treatment before the first scheduled disease assessment due to clinical progression or toxicity.
DCR was calculated as the number of participants whose best response was CR, PR, or SD, divided by the total number of participants evaluable for DCR analysis. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm. PR was defined as at least a 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=32 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=15 Participants
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
n=12 Participants
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=9 Participants
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
n=32 Participants
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
n=14 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Disease Control Rate
|
65.6 percentage of participants
Interval 49.6 to 79.4
|
60.0 percentage of participants
Interval 36.0 to 80.9
|
—
|
41.7 percentage of participants
Interval 18.1 to 68.5
|
77.8 percentage of participants
Interval 45.0 to 95.9
|
68.8 percentage of participants
Interval 52.8 to 82.0
|
42.9 percentage of participants
Interval 20.6 to 67.5
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 2 cycles for the first 4 cycles and then every 4 cycles thereafter until disease progression (Up to 82 months)Population: The efficacy analysis set included all participants who received any amount of study drug. Overall number of participants analyzed is the number of participants with data available for analysis.
Duration of response was calculated for all responders from the date of the earliest assessment of CR or PR to the date of relapse or death, whichever occurred earlier, or the last disease assessment date for participants without a relapse or death. Duration of SD was calculated for participants whose best response is CR, PR, or SD from the day study drug was first taken to the date of disease progression or death, whichever occurred earlier, or the last disease assessment for participants without disease progression or death.
Outcome measures
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=4 Participants
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 3 Dose Escalation
n=1 Participants
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
n=4 Participants
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
n=1 Participants
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Duration of Response
|
193.00 days
Interval 65.0 to 219.0
|
—
|
—
|
144.00 days
Interval 144.0 to 144.0
|
—
|
189.50 days
Interval 102.0 to 260.0
|
750.00 days
Interval 750.0 to 750.0
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 1A: Cohort 1 Dose Escalation
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase 1A: Cohort 2 Dose Escalation
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 1A: Cohort 3 Dose Escalation
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase 1A: Cohort 5 Dose Escalation
Serious events: 7 serious events
Other events: 8 other events
Deaths: 9 deaths
Phase 1A: Cohort 4 Dose Escalation
Serious events: 2 serious events
Other events: 5 other events
Deaths: 3 deaths
Phase 1A: Cohort 6 Dose Escalation
Serious events: 1 serious events
Other events: 6 other events
Deaths: 4 deaths
Phase 1A: Cohort 7 Dose Escalation
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase 1A: Cohort 8 Dose Escalation
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase 1A: Cohort 9 Dose Escalation
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase 1A: Cohort 10 Dose Escalation
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1A: Cohort 11 Dose Escalation
Serious events: 3 serious events
Other events: 7 other events
Deaths: 5 deaths
Phase 1A: Cohort 12 Dose Escalation
Serious events: 1 serious events
Other events: 7 other events
Deaths: 7 deaths
Phase 1B Dose Expansion
Serious events: 9 serious events
Other events: 20 other events
Deaths: 13 deaths
Phase 2: Cohort A
Serious events: 11 serious events
Other events: 31 other events
Deaths: 23 deaths
Phase 2: Cohort B
Serious events: 5 serious events
Other events: 15 other events
Deaths: 13 deaths
Phase 2: Cohort C
Serious events: 4 serious events
Other events: 12 other events
Deaths: 10 deaths
Phase 2: Cohort D
Serious events: 3 serious events
Other events: 9 other events
Deaths: 5 deaths
Phase 2: Cohort E
Serious events: 12 serious events
Other events: 32 other events
Deaths: 14 deaths
Phase 2: Cohort F
Serious events: 4 serious events
Other events: 13 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=3 participants at risk
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=3 participants at risk
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 3 Dose Escalation
n=3 participants at risk
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
n=10 participants at risk
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=5 participants at risk
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
n=6 participants at risk
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
n=3 participants at risk
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
n=3 participants at risk
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
n=3 participants at risk
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
n=3 participants at risk
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
n=7 participants at risk
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
n=7 participants at risk
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1B Dose Expansion
n=20 participants at risk
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 2: Cohort A
n=32 participants at risk
Participants with NRAS-mutant melanoma received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
Phase 2: Cohort B
n=15 participants at risk
Participants with KRAS-mutant or KRAS-amplified NSCLC received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
Phase 2: Cohort C
n=12 participants at risk
Participants with BRAF V600-mutant cancers (non-colorectal cancers) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
Phase 2: Cohort D
n=9 participants at risk
Participants with BRAF-fusion cancers received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
Phase 2: Cohort E
n=32 participants at risk
Participants with gynecological cancers with alterations in the MAPK pathway received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
Phase 2: Cohort F
n=14 participants at risk
Participants with tumors that were characterized by other gene aberrations (that upregulate the MAPK signal pathway) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
2/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Vascular disorders
Embolism venous
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Gastrointestinal stoma output decreased
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
General disorders
Malaise
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
General disorders
Organ failure
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
40.0%
4/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
16.7%
1/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Nervous system disorders
Intracranial mass
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
Other adverse events
| Measure |
Phase 1A: Cohort 1 Dose Escalation
n=3 participants at risk
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 2 Dose Escalation
n=3 participants at risk
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 3 Dose Escalation
n=3 participants at risk
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 5 Dose Escalation
n=10 participants at risk
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 4 Dose Escalation
n=5 participants at risk
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 6 Dose Escalation
n=6 participants at risk
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 7 Dose Escalation
n=3 participants at risk
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
|
Phase 1A: Cohort 8 Dose Escalation
n=3 participants at risk
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 9 Dose Escalation
n=3 participants at risk
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 10 Dose Escalation
n=3 participants at risk
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 11 Dose Escalation
n=7 participants at risk
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1A: Cohort 12 Dose Escalation
n=7 participants at risk
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 1B Dose Expansion
n=20 participants at risk
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
|
Phase 2: Cohort A
n=32 participants at risk
Participants with NRAS-mutant melanoma received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
Phase 2: Cohort B
n=15 participants at risk
Participants with KRAS-mutant or KRAS-amplified NSCLC received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
Phase 2: Cohort C
n=12 participants at risk
Participants with BRAF V600-mutant cancers (non-colorectal cancers) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
Phase 2: Cohort D
n=9 participants at risk
Participants with BRAF-fusion cancers received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
Phase 2: Cohort E
n=32 participants at risk
Participants with gynecological cancers with alterations in the MAPK pathway received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
Phase 2: Cohort F
n=14 participants at risk
Participants with tumors that were characterized by other gene aberrations (that upregulate the MAPK signal pathway) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
28.6%
2/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
2/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
21.9%
7/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
12.5%
4/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
2/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
30.0%
3/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
40.0%
2/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
66.7%
2/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
42.9%
3/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
35.0%
7/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
28.1%
9/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
3/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
41.7%
5/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
22.2%
2/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
43.8%
14/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
35.7%
5/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
12.5%
4/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
28.6%
2/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
16.7%
2/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
12.5%
4/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Ear and labyrinth disorders
Inner ear disorder
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Eye disorders
Dyschromatopsia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
42.9%
3/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
28.6%
2/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
2/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
15.6%
5/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
12.5%
4/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
28.6%
4/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Eye disorders
Visual field defect
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Eye disorders
Retinal degeneration
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Eye disorders
Diplopia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
2/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
General disorders
Catheter site erythema
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Eye disorders
Macular detachment
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Eye disorders
Retinopathy
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Eye disorders
Visual impairment
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
28.6%
2/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
2/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
9.4%
3/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
2/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Eye disorders
Central serous chorioretinopathy
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Eye disorders
Exophthalmos
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Eye disorders
Subretinal fluid
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Eye disorders
Detachment of retinal pigment epithelium
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Eye disorders
Eye disorder
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
2/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
13.3%
2/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Eye disorders
Presbyopia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Eye disorders
Blepharitis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Eye disorders
Keratitis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Eye disorders
Visual brightness
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
100.0%
3/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
40.0%
4/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
60.0%
3/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
16.7%
1/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
66.7%
2/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
66.7%
2/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
66.7%
2/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
42.9%
3/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
42.9%
3/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
35.0%
7/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
31.2%
10/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
53.3%
8/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
41.7%
5/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
44.4%
4/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
46.9%
15/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
21.4%
3/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
30.0%
3/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
2/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
42.9%
3/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
57.1%
4/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
50.0%
10/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
59.4%
19/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
40.0%
6/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
41.7%
5/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
66.7%
6/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
71.9%
23/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
57.1%
8/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
2/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
15.0%
3/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
15.6%
5/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
13.3%
2/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
22.2%
2/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
12.5%
4/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
21.4%
3/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
25.0%
5/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
28.1%
9/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
3/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
2/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Lip oedema
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
40.0%
2/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
16.7%
1/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
42.9%
3/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
30.0%
6/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
18.8%
6/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
26.7%
4/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
41.7%
5/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
22.2%
2/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
40.6%
13/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
21.4%
3/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Ascites
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
25.0%
5/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
13.3%
2/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
16.7%
2/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
2/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
9.4%
3/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
22.2%
2/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
15.6%
5/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
2/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
22.2%
2/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
21.4%
3/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
28.6%
2/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
9.4%
3/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
General disorders
Nodule
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
9.4%
3/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
13.3%
2/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
9.4%
3/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Tongue oedema
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Tongue haemorrhage
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
18.8%
6/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
General disorders
Chills
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
15.0%
3/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
13.3%
2/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
66.7%
2/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
66.7%
2/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
71.4%
5/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
42.9%
3/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
35.0%
7/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
31.2%
10/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
26.7%
4/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
25.0%
3/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
55.6%
5/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
46.9%
15/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
42.9%
6/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
General disorders
Oedema
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
4/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
15.6%
5/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
13.3%
2/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
General disorders
Generalised oedema
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
General disorders
Malaise
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
16.7%
1/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
15.0%
3/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
15.6%
5/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
22.2%
2/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
18.8%
6/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
21.4%
3/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
General disorders
Secretion discharge
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
General disorders
Catheter site pain
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
General disorders
Injection site bruising
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
General disorders
Localised oedema
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
General disorders
Pain
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
General disorders
Face oedema
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
General disorders
Thirst
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
2/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Paronychia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
28.6%
2/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
15.0%
3/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
12.5%
4/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
21.9%
7/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
2/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Ear infection
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
2/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
16.7%
1/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Injection site infection
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
15.6%
5/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
22.2%
2/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
22.2%
2/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Periorbital infection
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Infections and infestations
Urethritis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
2/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
50.0%
5/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
2/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
66.7%
2/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
28.6%
2/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
2/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
18.8%
6/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
9.4%
3/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
2/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
30.0%
3/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
16.7%
1/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
66.7%
2/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
15.6%
5/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
18.8%
6/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
66.7%
2/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
2/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
16.7%
1/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
9.4%
3/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
13.3%
2/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
22.2%
2/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
16.7%
1/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Weight decreased
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Blood glucose increased
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
16.7%
1/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
16.7%
1/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
9.4%
3/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
22.2%
2/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Ammonia increased
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
9.4%
3/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Weight increased
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
9.4%
3/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
13.3%
2/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Amylase increased
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Blood corticotrophin decreased
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Blood creatine increased
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Blood iron decreased
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Blood potassium increased
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
15.0%
3/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
18.8%
6/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
5/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
16.7%
2/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
22.2%
2/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
28.1%
9/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
18.8%
6/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
12.5%
4/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
15.6%
5/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
16.7%
1/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
16.7%
1/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
42.9%
3/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
15.0%
3/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
13.3%
2/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
15.6%
5/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
40.0%
2/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
28.6%
2/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
2/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
3/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
15.6%
5/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
28.6%
2/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
16.7%
1/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
12.5%
4/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
21.9%
7/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
15.0%
3/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
28.6%
2/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
12.5%
4/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
15.6%
5/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
9.4%
3/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
2/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
2/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
2/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Connective tissue disorder
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
16.7%
1/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
2/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
12.5%
4/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
9.4%
3/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
2/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Nervous system disorders
Ophthalmic migraine
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
2/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
2/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
2/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
9.4%
3/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
22.2%
2/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
9.4%
3/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
16.7%
1/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
2/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
9.4%
3/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
13.3%
2/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
16.7%
2/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
3/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
12.5%
4/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
2/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Lung opacity
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
2/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
18.8%
6/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
13.3%
2/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
25.0%
3/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
2/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
16.7%
1/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
4/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
12.5%
4/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
26.7%
4/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
12.5%
4/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
21.4%
3/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
28.6%
2/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
15.0%
3/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
18.8%
6/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
26.7%
4/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
16.7%
2/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
28.1%
9/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
2/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
16.7%
1/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
42.9%
3/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
28.6%
2/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
4/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
18.8%
6/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
13.3%
2/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
9.4%
3/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
21.4%
3/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin indentation
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
20.0%
1/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
10.0%
1/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.2%
2/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
6.7%
1/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
3.1%
1/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
8.3%
1/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
7.1%
1/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural contusion
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Venous injury
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
14.3%
1/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
33.3%
1/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/10 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/5 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/6 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/3 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/7 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
5.0%
1/20 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/15 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/12 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
11.1%
1/9 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/32 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
0.00%
0/14 • From first dose of study drug up to end of the study (Up to 82 months)
The Safety Analysis Set included data from all participants who received any amount of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER