Trial Outcomes & Findings for A Study of Olaratumab Alone and in Combination With Standard Chemotherapies in Children With Cancer (NCT NCT02677116)
NCT ID: NCT02677116
Last Updated: 2020-05-20
Results Overview
A dose limiting toxicity (DLT) was defined as an adverse event (AE) during the first 21 days that was possibly related to the study drug and fulfilled any of the following criteria using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0: CTCAE Grade 3 nonhematologic toxicity, grade 4 neutropenia that lasted longer than 2 weeks, grade ≥3 thrombocytopenia complicated by hemorrhage, and any hematologic toxicity that caused a cycle delay of \>14 days.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
68 participants
Primary outcome timeframe
Parts A and B: Cycle 1 through Cycle 2 in each arm (21-day cycle); Part C: Cycle 1 only (21-day cycle)
Results posted on
2020-05-20
Participant Flow
Completers include the participants who died due to any cause or disease progression, alive and on study at conclusion, but off treatment.
Participant milestones
| Measure |
Olaratumab + Vincristine + Irinotecan (Part A)
Cycle 1: Olaratumab 15 milligram/kilogram (mg/kg) was administered alone intravenously (IV) on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part A)
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. . Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part A)
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part B)
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part B)
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part B)
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part C)
Cycle 1 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part C)
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part C)
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
9
|
10
|
1
|
13
|
6
|
4
|
4
|
|
Overall Study
Cycle 1 Olaratumab Alone
|
10
|
11
|
9
|
10
|
1
|
13
|
6
|
4
|
4
|
|
Overall Study
Progressive Disease
|
7
|
7
|
6
|
7
|
0
|
9
|
2
|
2
|
2
|
|
Overall Study
COMPLETED
|
7
|
7
|
6
|
7
|
0
|
9
|
2
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
3
|
3
|
1
|
4
|
4
|
2
|
2
|
Reasons for withdrawal
| Measure |
Olaratumab + Vincristine + Irinotecan (Part A)
Cycle 1: Olaratumab 15 milligram/kilogram (mg/kg) was administered alone intravenously (IV) on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part A)
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. . Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part A)
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part B)
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part B)
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part B)
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part C)
Cycle 1 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part C)
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part C)
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
2
|
3
|
2
|
1
|
3
|
1
|
1
|
2
|
|
Overall Study
Withdrawal by parent or guardian
|
2
|
1
|
0
|
1
|
0
|
0
|
2
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of Olaratumab Alone and in Combination With Standard Chemotherapies in Children With Cancer
Baseline characteristics by cohort
| Measure |
Olaratumab + Vincristine + Irinotecan (Part A)
n=10 Participants
Cycle 1: Olaratumab 15 milligram/kilogram (mg/kg) was administered alone intravenously (IV) on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part A)
n=11 Participants
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part A)
n=9 Participants
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part B)
n=10 Participants
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part B)
n=1 Participants
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part B)
n=13 Participants
Cycle1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part C)
n=6 Participants
Cycle 1 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part C)
n=4 Participants
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 though 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part C)
n=4 Participants
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
9.9 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
6.8 years
STANDARD_DEVIATION 4.3 • n=7 Participants
|
10.7 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
10.6 years
STANDARD_DEVIATION 4.9 • n=4 Participants
|
NA years
STANDARD_DEVIATION NA • n=21 Participants
|
12.5 years
STANDARD_DEVIATION 3.8 • n=8 Participants
|
9.7 years
STANDARD_DEVIATION 5.4 • n=8 Participants
|
8.0 years
STANDARD_DEVIATION 7.0 • n=24 Participants
|
10.8 years
STANDARD_DEVIATION 5.1 • n=42 Participants
|
10.0 years
STANDARD_DEVIATION 4.8 • n=42 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
28 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
40 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
46 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
3 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
43 Participants
n=42 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
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
59 Participants
n=42 Participants
|
|
Region of Enrollment
Japan
|
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
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Parts A and B: Cycle 1 through Cycle 2 in each arm (21-day cycle); Part C: Cycle 1 only (21-day cycle)Population: All participants who received at least one dose of study drug and had DLTs.
A dose limiting toxicity (DLT) was defined as an adverse event (AE) during the first 21 days that was possibly related to the study drug and fulfilled any of the following criteria using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0: CTCAE Grade 3 nonhematologic toxicity, grade 4 neutropenia that lasted longer than 2 weeks, grade ≥3 thrombocytopenia complicated by hemorrhage, and any hematologic toxicity that caused a cycle delay of \>14 days.
Outcome measures
| Measure |
Olaratumab + Ifosfamide (Part B)
n=13 Participants
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 though 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part B)
n=1 Participants
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part C)
n=6 Participants
Cycle 1 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part C)
n=4 Participants
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part C)
n=4 Participants
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part A)
n=10 Participants
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part A)
n=9 Participants
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part A)
n=11 Participants
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part B)
n=10 Participants
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Olaratumab Dose Limiting Toxicities (DLTs)
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Cycle 1, Day 8 and Cycle 2, Days 1 and 8: 1.25 hour (h), 2.5 h, 3.5h PostdosePopulation: All participants who had evaluable PK individual serum concentration samples analyzed for Cycle 1 Olaratumab alone and Cycle 2 Olaratumab combinations for Part A.
Pharmacokinetics (PK): Maximum serum concentration (Cmax) data of Olaratumab was reported from available sample data.
Outcome measures
| Measure |
Olaratumab + Ifosfamide (Part B)
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 though 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part B)
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part C)
Cycle 1 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part C)
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part C)
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part A)
n=28 Participants
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part A)
n=6 Participants
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part A)
n=9 Participants
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part B)
n=7 Participants
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab Part A
Cycle 1, Day 8
|
—
|
—
|
—
|
—
|
—
|
439 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 23
|
—
|
—
|
—
|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab Part A
Cycle 2, Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
406 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 21
|
396 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 39
|
437 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 44
|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab Part A
Cycle 2, Day 8
|
—
|
—
|
—
|
—
|
—
|
—
|
422 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 30
|
398 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 44
|
523 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 26
|
SECONDARY outcome
Timeframe: Cycle 1, Day 8 and Cycle 2, Days 1 and 8: 1.25 hour (h), 2.5 h, 3.5h PostdosePopulation: All participants who had evaluable PK individual serum concentration samples analyzed for Cycle 1 Olaratumab alone and Cycle 2 Olaratumab combinations for Part B. Zero participants analyzed for Olaratumab and Doxorubicin being below the quantifiable limit.
PK: Maximum serum concentration (Cmax) data of Olaratumab was reported from available sample data.
Outcome measures
| Measure |
Olaratumab + Ifosfamide (Part B)
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 though 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part B)
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part C)
Cycle 1 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part C)
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part C)
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part A)
n=21 Participants
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part A)
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part A)
n=11 Participants
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part B)
n=8 Participants
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
PK: Maximum Concentration (Cmax) of Olaratumab Part B
Cycle 1, Day 8
|
—
|
—
|
—
|
—
|
—
|
639 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 27
|
—
|
—
|
—
|
|
PK: Maximum Concentration (Cmax) of Olaratumab Part B
Cycle 2, Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
629 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 32
|
585 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 30
|
|
PK: Maximum Concentration (Cmax) of Olaratumab Part B
Cycle 2, Day 8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
696 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 27
|
647 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 27
|
SECONDARY outcome
Timeframe: Cycle 1, Days 1 and 8; Cycle 2, Days 1 and 8: 1.25 hour (h), 2.5 h, 3.5h PostdosePopulation: All participants who had evaluable PK individual serum concentration samples analyzed for Cycle 1 and 2 for all Part C treatment combinations. Per protocol, the Part C olaratumab alone was not collected.
Pharmacokinetics (PK): Maximum serum concentration (Cmax) data of Olaratumab was reported from available sample data.
Outcome measures
| Measure |
Olaratumab + Ifosfamide (Part B)
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 though 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part B)
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part C)
Cycle 1 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part C)
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part C)
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part A)
n=4 Participants
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part A)
n=3 Participants
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part A)
n=6 Participants
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part B)
n=4 Participants
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
PK: Maximum Concentration (Cmax) of Olaratumab Part C
Cycle 1, Day 1
|
—
|
—
|
—
|
—
|
—
|
406 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 20
|
—
|
548 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 15
|
363 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 39
|
|
PK: Maximum Concentration (Cmax) of Olaratumab Part C
Cycle 1, Day 8
|
—
|
—
|
—
|
—
|
—
|
493 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 20
|
—
|
695 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 37
|
498 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 43
|
|
PK: Maximum Concentration (Cmax) of Olaratumab Part C
Cycle 2, Day 8
|
—
|
—
|
—
|
—
|
—
|
—
|
502 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 38
|
707 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 3
|
567 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 38
|
SECONDARY outcome
Timeframe: Cycles 1, 2, 3-25; Day 8: 336 Hours PostdosePopulation: All participants who had evaluable PK individual serum concentration samples analyzed for Cycle 1 Olaratumab alone and Cycle 2 and 3-25 Olaratumab combinations for Part A.
PK: Trough serum concentration (Cmin) of Olaratumab was reported. A sample was collected every other cycle from cycles 1, 2, 3-25.
Outcome measures
| Measure |
Olaratumab + Ifosfamide (Part B)
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 though 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part B)
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part C)
Cycle 1 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part C)
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part C)
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part A)
n=6 Participants
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part A)
n=5 Participants
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part A)
n=9 Participants
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part B)
n=17 Participants
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
PK: Trough Serum Minimum Concentration (Cmin) of Olaratumab Part A
Cycle 1, Day 8
|
—
|
—
|
—
|
—
|
—
|
73 μg/mL
Geometric Coefficient of Variation 56
|
—
|
46.3 μg/mL
Geometric Coefficient of Variation 284
|
97.8 μg/mL
Geometric Coefficient of Variation 29
|
|
PK: Trough Serum Minimum Concentration (Cmin) of Olaratumab Part A
Cycle 2, Day 8
|
—
|
—
|
—
|
—
|
—
|
—
|
38.5 μg/mL
Geometric Coefficient of Variation 29.1
|
114 μg/mL
Geometric Coefficient of Variation 85
|
37.7 μg/mL
Geometric Coefficient of Variation 112
|
|
PK: Trough Serum Minimum Concentration (Cmin) of Olaratumab Part A
Cycle 3-25, Day 8
|
—
|
—
|
—
|
—
|
—
|
—
|
94.4 μg/mL
Geometric Coefficient of Variation 41
|
88.2 μg/mL
Geometric Coefficient of Variation 77
|
95.1 μg/mL
Geometric Coefficient of Variation 85
|
SECONDARY outcome
Timeframe: Cycles 1, 2, 3-25; Day 8: 336 Hours PostdosePopulation: All participants who had evaluable PK individual serum concentration samples analyzed for Cycle 1, 2 and Cycle 3-25 Olaratumab combinations for Part B.
PK: Trough serum concentration (Cmin) of Olaratumab was reported. A sample was collected every other cycle from cycles 1, 2, 3-25.
Outcome measures
| Measure |
Olaratumab + Ifosfamide (Part B)
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 though 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part B)
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part C)
Cycle 1 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part C)
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part C)
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part A)
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part A)
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part A)
n=11 Participants
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part B)
n=9 Participants
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
PK: Trough Serum Minimum Concentration (Cmin) of Olaratumab Part B
Cycle 1, Day 8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
125 μg/mL
Geometric Coefficient of Variation 55
|
99.1 μg/mL
Geometric Coefficient of Variation 65
|
|
PK: Trough Serum Minimum Concentration (Cmin) of Olaratumab Part B
Cycle 2, Day 8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
199 μg/mL
Geometric Coefficient of Variation 36
|
230 μg/mL
Geometric Coefficient of Variation 17
|
|
PK: Trough Serum Minimum Concentration (Cmin) of Olaratumab Part B
Cycle 3-25, Day 8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
289 μg/mL
Geometric Coefficient of Variation 14
|
348 μg/mL
Geometric Coefficient of Variation 15
|
SECONDARY outcome
Timeframe: Cycles 1, 2, 3-25; Day 8: 336 Hours PostdosePopulation: All participants who had evaluable PK individual serum concentration samples analyzed for Cycle 1, 2 and Cycle 3-25 Olaratumab combinations for Part C.
PK: Trough serum concentration (Cmin) of Olaratumab was reported. A sample was collected every other cycle from cycles 1, 2, 3-25.
Outcome measures
| Measure |
Olaratumab + Ifosfamide (Part B)
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 though 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part B)
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part C)
Cycle 1 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part C)
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part C)
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part A)
n=3 Participants
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part A)
n=5 Participants
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part A)
n=3 Participants
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part B)
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
PK: Trough Serum Minimum Concentration (Cmin) of Olaratumab Part C
Cycle 1, Day 8
|
—
|
—
|
—
|
—
|
—
|
90.3 μg/mL
Geometric Coefficient of Variation 33
|
83.7 μg/mL
Geometric Coefficient of Variation 8
|
124 μg/mL
Geometric Coefficient of Variation 32
|
—
|
|
PK: Trough Serum Minimum Concentration (Cmin) of Olaratumab Part C
Cycle 2, Day 8
|
—
|
—
|
—
|
—
|
—
|
141 μg/mL
Geometric Coefficient of Variation 18
|
134 μg/mL
Geometric Coefficient of Variation 54
|
NA μg/mL
Geometric Coefficient of Variation NA
Geometric mean and geometric coefficient of variation (CV) was not calculated due to one participant; individual participant data reported: 250.
|
—
|
|
PK: Trough Serum Minimum Concentration (Cmin) of Olaratumab Part C
Cycle 3-25, Day 8
|
—
|
—
|
—
|
—
|
—
|
156 μg/mL
Geometric Coefficient of Variation 24
|
83.7 μg/mL
Geometric Coefficient of Variation 48
|
NA μg/mL
Geometric Coefficient of Variation NA
Geometric mean and geometric coefficient of variation (CV) was not calculated due to one participant; individual participant data reported: 210.
|
—
|
SECONDARY outcome
Timeframe: Baseline to objective progression or start of new anti-cancer therapy (Up to 7 months)Population: All participants who received at least one dose of study drug and had evaluable ORR data.
Objective Response Rate (ORR) is the percentage of participants achieving a confirmed best overall tumor response of CR or PR. According to RECIST v1.1, PR defined as a \>30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; CR was defined as the disappearance of all target and non-target lesions.
Outcome measures
| Measure |
Olaratumab + Ifosfamide (Part B)
n=13 Participants
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 though 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part B)
n=1 Participants
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part C)
n=6 Participants
Cycle 1 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part C)
n=4 Participants
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part C)
n=4 Participants
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part A)
n=10 Participants
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part A)
n=9 Participants
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part A)
n=11 Participants
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part B)
n=10 Participants
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
9.1 percentage of participants
|
20.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to radiological disease progression or death from any cause (Up to 2 Years)Population: All participants who received at least one dose of study drug. Censored participants: Parts A-C include arms: Olaratumab + Vincristine + Irinotecan, Olaratumab + Ifosfamide and Olaratumab + Doxorubicin. Part A censored participants are 2, 2, and 2; Part B censored participants are 2, 2, and 1 and Part C censored participants are 2,1, and 4.
Progression-free survival (PFS) is defined as the time from baseline to the first date of radiological disease progression or death due to any cause. Progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions is also considered progression. If participant started new treatment before PD, the participant was censored at the date of last tumor assessment prior to new therapy. If treatment was discontinued for reasons other than PD and no further assessment, censoring occurred at last tumor assessment.
Outcome measures
| Measure |
Olaratumab + Ifosfamide (Part B)
n=13 Participants
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 though 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part B)
n=1 Participants
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part C)
n=6 Participants
Cycle 1 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part C)
n=4 Participants
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part C)
n=4 Participants
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part A)
n=10 Participants
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part A)
n=9 Participants
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part A)
n=11 Participants
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part B)
n=10 Participants
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
1.25 Months
Interval 1.15 to 3.12
|
NA Months
The PFS was not calculated for median and 95% confidence interval due to n=1.
|
4.07 Months
Interval 1.41 to 4.07
|
4.88 Months
Interval 0.69 to 8.54
|
5.52 Months
Interval 1.22 to 5.52
|
1.54 Months
Interval 0.69 to 15.74
|
1.38 Months
Interval 0.62 to 5.68
|
1.26 Months
Interval 0.26 to 5.26
|
1.28 Months
Interval 0.53 to 11.07
|
SECONDARY outcome
Timeframe: From Baseline to Study Completion (Up to 33 Months)Population: All participants who received at least one dose of study drug and had evaluable baseline sample and at least 1 evaluable post baseline sample.
Percentage of participants with a TE positive anti-olaratumab antibodies defined as a participant with a 4-fold (2 dilutions) increase over a positive baseline antibody titer.
Outcome measures
| Measure |
Olaratumab + Ifosfamide (Part B)
n=13 Participants
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 though 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part B)
n=1 Participants
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part C)
n=6 Participants
Cycle 1 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part C)
n=4 Participants
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part C)
n=4 Participants
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part A)
n=10 Participants
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part A)
n=9 Participants
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part A)
n=11 Participants
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part B)
n=10 Participants
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment Emergent (TE) Positive Anti-Olaratumab Antibodies
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Olaratumab + Vincristine + Irinotecan (Part A)
Serious events: 3 serious events
Other events: 10 other events
Deaths: 2 deaths
Olaratumab + Ifosfamide (Part A)
Serious events: 4 serious events
Other events: 9 other events
Deaths: 1 deaths
Olaratumab + Doxorubicin (Part A)
Serious events: 2 serious events
Other events: 11 other events
Deaths: 2 deaths
Olaratumab + Vincristine + Irinotecan (Part B)
Serious events: 5 serious events
Other events: 9 other events
Deaths: 2 deaths
Olaratumab + Ifosfamide (Part B)
Serious events: 7 serious events
Other events: 13 other events
Deaths: 2 deaths
Olaratumab + Doxorubicin (Part B)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Olaratumab + Vincristine + Irinotecan (Part C)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Olaratumab + Ifosfamide (Part C)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Olaratumab + Doxorubicin (Part C)
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Olaratumab + Vincristine + Irinotecan (Part A)
n=10 participants at risk
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part A)
n=9 participants at risk
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part A)
n=11 participants at risk
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part B)
n=10 participants at risk
Cycle 1: Olaratumab 20 mg/kg administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part B)
n=13 participants at risk
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part B)
n=1 participants at risk
Cycle 1: Olaratumab 20 mg/kg alone was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part C)
n=6 participants at risk
Cycle 1 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part C)
n=4 participants at risk
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part C)
n=4 participants at risk
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
22.2%
2/9 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
46.2%
6/13 • Number of events 8 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
2/4 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Methaemoglobinaemia
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
30.0%
3/10 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 5 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pain
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Influenza
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Lung infection
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Penile infection
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/8 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Staphylococcus test positive
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
20.0%
2/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Seizure
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
Other adverse events
| Measure |
Olaratumab + Vincristine + Irinotecan (Part A)
n=10 participants at risk
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part A)
n=9 participants at risk
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part A)
n=11 participants at risk
Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part B)
n=10 participants at risk
Cycle 1: Olaratumab 20 mg/kg administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part B)
n=13 participants at risk
Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part B)
n=1 participants at risk
Cycle 1: Olaratumab 20 mg/kg alone was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Vincristine + Irinotecan (Part C)
n=6 participants at risk
Cycle 1 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Ifosfamide (Part C)
n=4 participants at risk
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
Olaratumab + Doxorubicin (Part C)
n=4 participants at risk
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
20.0%
2/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gingival bleeding
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Protein total decreased
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Weight decreased
|
20.0%
2/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
23.1%
3/13 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Anaemia
|
40.0%
4/10 • Number of events 9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
77.8%
7/9 • Number of events 36 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
54.5%
6/11 • Number of events 11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
5/10 • Number of events 18 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
61.5%
8/13 • Number of events 55 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
66.7%
4/6 • Number of events 12 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
75.0%
3/4 • Number of events 5 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
100.0%
4/4 • Number of events 11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
2/4 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
2/4 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Leukopenia
|
10.0%
1/10 • Number of events 7 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
20.0%
2/10 • Number of events 16 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
15.4%
2/13 • Number of events 9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
3/6 • Number of events 21 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
2/4 • Number of events 16 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
75.0%
3/4 • Number of events 23 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
10.0%
1/10 • Number of events 6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 7 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
15.4%
2/13 • Number of events 7 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
2/4 • Number of events 6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
75.0%
3/4 • Number of events 26 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.0%
1/10 • Number of events 8 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
20.0%
2/10 • Number of events 26 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
15.4%
2/13 • Number of events 8 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
66.7%
4/6 • Number of events 19 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
2/4 • Number of events 13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
75.0%
3/4 • Number of events 24 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
1/10 • Number of events 16 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 7 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
23.1%
3/13 • Number of events 14 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
33.3%
2/6 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
75.0%
3/4 • Number of events 15 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Sinus bradycardia
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Sinus tachycardia
|
20.0%
2/10 • Number of events 8 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 7 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
15.4%
2/13 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Tachycardia
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Endocrine disorders
Hyperthyroidism
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Endocrine disorders
Hypothyroidism
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Dry eye
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Eye pain
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Eye swelling
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Swelling of eyelid
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Vision blurred
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal distension
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
2/10 • Number of events 9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
5/10 • Number of events 10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
15.4%
2/13 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
33.3%
2/6 • Number of events 6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
1/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Cheilitis
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
30.0%
3/10 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
33.3%
3/9 • Number of events 6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
30.0%
3/10 • Number of events 6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
15.4%
2/13 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
2/4 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dental caries
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
60.0%
6/10 • Number of events 41 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
70.0%
7/10 • Number of events 20 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
100.0%
6/6 • Number of events 21 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
2/4 • Number of events 6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
23.1%
3/13 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haematemesis
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
5/10 • Number of events 31 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
44.4%
4/9 • Number of events 12 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
36.4%
4/11 • Number of events 5 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
70.0%
7/10 • Number of events 24 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
69.2%
9/13 • Number of events 34 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
100.0%
1/1 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
33.3%
2/6 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
75.0%
3/4 • Number of events 10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
75.0%
3/4 • Number of events 5 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Proctalgia
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Retching
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Stomatitis
|
30.0%
3/10 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
20.0%
2/10 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
15.4%
2/13 • Number of events 6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
2/4 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
70.0%
7/10 • Number of events 34 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
55.6%
5/9 • Number of events 17 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
36.4%
4/11 • Number of events 8 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
5/10 • Number of events 14 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
61.5%
8/13 • Number of events 11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
3/6 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
2/4 • Number of events 7 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
2/4 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Catheter site pain
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Chills
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Early satiety
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Face oedema
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Facial pain
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Fatigue
|
60.0%
6/10 • Number of events 15 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
22.2%
2/9 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
36.4%
4/11 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
30.0%
3/10 • Number of events 6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
30.8%
4/13 • Number of events 5 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Gait disturbance
|
20.0%
2/10 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Localised oedema
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Malaise
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Non-cardiac chest pain
|
20.0%
2/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
20.0%
2/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Oedema peripheral
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
20.0%
2/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
15.4%
2/13 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pain
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
20.0%
2/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
22.2%
2/9 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
27.3%
3/11 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
40.0%
4/10 • Number of events 10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
2/4 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Candida infection
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Clostridium difficile infection
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Cystitis
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Lymph gland infection
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Skin infection
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Contusion
|
30.0%
3/10 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
18.2%
2/11 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
20.0%
2/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Platelet count decreased
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
77.8%
7/9 • Number of events 43 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
27.3%
3/11 • Number of events 12 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
38.5%
5/13 • Number of events 30 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
3/6 • Number of events 11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 8 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
18.2%
2/11 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Ph urine increased
|
10.0%
1/10 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Recall phenomenon
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Activated partial thromboplastin time
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
20.0%
2/10 • Number of events 5 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
2/10 • Number of events 9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
22.2%
2/9 • Number of events 9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
15.4%
2/13 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
100.0%
1/1 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
3/6 • Number of events 7 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
2/4 • Number of events 8 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
2/10 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
44.4%
4/9 • Number of events 6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
30.8%
4/13 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
100.0%
1/1 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
3/6 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
2/4 • Number of events 7 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood alkaline phosphatase increased
|
20.0%
2/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
22.2%
2/9 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood bicarbonate decreased
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
15.4%
2/13 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood bilirubin increased
|
20.0%
2/10 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood creatinine increased
|
10.0%
1/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Electrocardiogram pr shortened
|
10.0%
1/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Electrocardiogram qt prolonged
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Eosinophil percentage decreased
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
44.4%
4/9 • Number of events 7 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
100.0%
1/1 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Haemoglobin increased
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Heart rate irregular
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
International normalised ratio increased
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Lymphocyte count decreased
|
20.0%
2/10 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
55.6%
5/9 • Number of events 29 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
18.2%
2/11 • Number of events 6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
30.0%
3/10 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
33.3%
2/6 • Number of events 11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Neutrophil count decreased
|
30.0%
3/10 • Number of events 16 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
33.3%
3/9 • Number of events 13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
45.5%
5/11 • Number of events 22 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
30.0%
3/10 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
23.1%
3/13 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
2/4 • Number of events 9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 7 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Weight increased
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 5 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
15.4%
2/13 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
White blood cell count decreased
|
20.0%
2/10 • Number of events 15 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
77.8%
7/9 • Number of events 45 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
27.3%
3/11 • Number of events 21 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
30.0%
3/10 • Number of events 8 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
30.8%
4/13 • Number of events 16 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
2/4 • Number of events 13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
White blood cell count increased
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
22.2%
2/9 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
15.4%
2/13 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
40.0%
4/10 • Number of events 8 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
18.2%
2/11 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
20.0%
2/10 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
23.1%
3/13 • Number of events 5 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
33.3%
2/6 • Number of events 5 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
2/4 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
2/4 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
2/10 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
30.0%
3/10 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperalbuminaemia
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 5 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
30.0%
3/10 • Number of events 9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
22.2%
2/9 • Number of events 10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
30.8%
4/13 • Number of events 11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
2/4 • Number of events 5 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
18.2%
2/11 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
20.0%
2/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
10.0%
1/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
22.2%
2/9 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 5 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.0%
1/10 • Number of events 5 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
33.3%
3/9 • Number of events 5 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
20.0%
2/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
23.1%
3/13 • Number of events 6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
2/4 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
30.0%
3/10 • Number of events 12 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
44.4%
4/9 • Number of events 5 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
15.4%
2/13 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.0%
2/10 • Number of events 5 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
22.2%
2/9 • Number of events 8 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
20.0%
2/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
38.5%
5/13 • Number of events 14 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
2/4 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
23.1%
3/13 • Number of events 7 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
20.0%
2/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
44.4%
4/9 • Number of events 5 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
38.5%
5/13 • Number of events 16 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
20.0%
2/10 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
22.2%
2/9 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
18.2%
2/11 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
30.0%
3/10 • Number of events 5 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
30.8%
4/13 • Number of events 14 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypouricaemia
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Refeeding syndrome
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
2/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
30.8%
4/13 • Number of events 6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
100.0%
1/1 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
2/10 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
22.2%
2/9 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
20.0%
2/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
15.4%
2/13 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
40.0%
4/10 • Number of events 8 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
22.2%
2/9 • Number of events 5 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
60.0%
6/10 • Number of events 8 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
30.8%
4/13 • Number of events 5 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
2/4 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
15.4%
2/13 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.0%
1/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
100.0%
1/1 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
2/10 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
18.2%
2/11 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
23.1%
3/13 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
10.0%
1/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
33.3%
3/9 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
20.0%
2/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dysgeusia
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Hemiparesis
|
10.0%
1/10 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Lethargy
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
10.0%
1/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Somnolence
|
10.0%
1/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Writer's cramp
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
15.4%
2/13 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Depression
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
30.0%
3/10 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
20.0%
2/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Mood swings
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Fanconi syndrome acquired
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
23.1%
3/13 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Ketonuria
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
15.4%
2/13 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Proteinuria
|
30.0%
3/10 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
23.1%
3/13 • Number of events 5 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Urinary retention
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Bradypnoea
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
18.2%
2/11 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
20.0%
2/10 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
30.8%
4/13 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
3/6 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
2/4 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
2/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
20.0%
2/10 • Number of events 5 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
18.2%
2/11 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
30.0%
3/10 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
1/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
20.0%
2/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
100.0%
1/1 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
10.0%
1/10 • Number of events 10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
15.4%
2/13 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Acne
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
36.4%
4/11 • Number of events 5 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
10.0%
1/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
15.4%
2/13 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
22.2%
2/9 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
30.0%
3/10 • Number of events 5 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
2/10 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
40.0%
4/10 • Number of events 6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
20.0%
2/10 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
18.2%
2/11 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Embolism
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Flushing
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
100.0%
1/1 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
1/6 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Haematoma
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
1/11 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
15.4%
2/13 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hypotension
|
30.0%
3/10 • Number of events 3 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
15.4%
2/13 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Pallor
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
15.4%
2/13 • Number of events 2 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Pelvic venous thrombosis
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Phlebitis
|
10.0%
1/10 • Number of events 1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/9 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/6 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Up to 33 Months.
All participants who received at least one dose of study drug up to 30 days after last dose of study drug. Gender specific events only occurring in male and female participants have had the number of participants At Risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60