Trial Outcomes & Findings for A Phase I Study of MK-2206 in Combination With Standard Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors (MK-2206-003) (NCT NCT00848718)
NCT ID: NCT00848718
Last Updated: 2019-11-12
Results Overview
A DLT was any of the following deemed drug related by investigator and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 criteria: Grade (G)4 hematologic toxicity lasting ≥7 days; G4 thrombocytopenia; G3 or 4 febrile neutropenia and/or infection requiring treatment; G3, 4, 5 non-hematologic toxicity(with the exception of G3 nausea, vomiting, diarrhea, dehydration, or hyperglycemia that as a result of inadequate compliance with supportive care measures; alopecia, inadequately treated hypersensitivity reactions G3 elevated transaminases of ≤1 week in duration); adverse experience (AE) leading to dose reduction; unresolved toxicity causing ≥3 week delay in treatment; ≥G3 hyperglycemia; persistent increases in QTc interval; clinically significant bradycardia; and missing MK-2206 doses due to toxicity. The number of participants who experienced a DLT is presented.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
77 participants
Primary outcome timeframe
Cycle 1 (Up to 21 days)
Results posted on
2019-11-12
Participant Flow
77 participants were allocated to one of 3 treatment combinations with MK-2206 according to clinical presentation but 5 participants were not treated due to disease progression before initiation of treatment.
Participant milestones
| Measure |
MK-2206 45 mg QOD+Carboplatin+Paclitaxel
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 60 mg QOD+Carboplatin+Paclitaxel
Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 90 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 135 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 200 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 45 mg QOD+Docetaxel 75 mg/m^2
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 90 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 135 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 200 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 45 mg QOD+Erlotinib 100 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 45 mg QOD+Erlotinib 150 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 100 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 150 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
9
|
6
|
5
|
6
|
5
|
3
|
5
|
4
|
9
|
4
|
6
|
8
|
|
Overall Study
Treated
|
6
|
9
|
5
|
5
|
6
|
5
|
3
|
4
|
4
|
9
|
4
|
6
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
6
|
5
|
6
|
5
|
3
|
5
|
4
|
9
|
4
|
6
|
8
|
Reasons for withdrawal
| Measure |
MK-2206 45 mg QOD+Carboplatin+Paclitaxel
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 60 mg QOD+Carboplatin+Paclitaxel
Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 90 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 135 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 200 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 45 mg QOD+Docetaxel 75 mg/m^2
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 90 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 135 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 200 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 45 mg QOD+Erlotinib 100 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 45 mg QOD+Erlotinib 150 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 100 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 150 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
1
|
1
|
1
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
1
|
1
|
0
|
0
|
1
|
2
|
0
|
0
|
1
|
|
Overall Study
Progressive disease before treatment
|
1
|
5
|
1
|
3
|
4
|
4
|
2
|
1
|
2
|
7
|
3
|
6
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Progressive disease during treatment
|
3
|
0
|
3
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
A Phase I Study of MK-2206 in Combination With Standard Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors (MK-2206-003)
Baseline characteristics by cohort
| Measure |
MK-2206 45 mg QOD+Carboplatin+Paclitaxel
n=7 Participants
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 60 mg QOD+Carboplatin+Paclitaxel
n=9 Participants
Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 90 mg Q3W+Carboplatin+Paclitaxel
n=6 Participants
Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 135 mg Q3W+Carboplatin+Paclitaxel
n=5 Participants
Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 200 mg Q3W+Carboplatin+Paclitaxel
n=6 Participants
Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 45 mg QOD+Docetaxel 75 mg/m^2
n=5 Participants
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 90 mg Q3W+Docetaxel 60 mg/m^2
n=3 Participants
Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 135 mg Q3W+Docetaxel 60 mg/m^2
n=5 Participants
Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 200 mg Q3W+Docetaxel 60 mg/m^2
n=4 Participants
Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 45 mg QOD+Erlotinib 100 mg
n=9 Participants
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 45 mg QOD+Erlotinib 150 mg
n=4 Participants
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 100 mg
n=6 Participants
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 150 mg
n=8 Participants
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
51.6 Years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
58.4 Years
STANDARD_DEVIATION 13.6 • n=7 Participants
|
56.2 Years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
63.6 Years
STANDARD_DEVIATION 7.8 • n=4 Participants
|
38.8 Years
STANDARD_DEVIATION 12.4 • n=21 Participants
|
57.4 Years
STANDARD_DEVIATION 19.7 • n=10 Participants
|
64.7 Years
STANDARD_DEVIATION 12.0 • n=115 Participants
|
57.4 Years
STANDARD_DEVIATION 8.0 • n=24 Participants
|
54.0 Years
STANDARD_DEVIATION 9.4 • n=42 Participants
|
61.6 Years
STANDARD_DEVIATION 6.1 • n=42 Participants
|
61.0 Years
STANDARD_DEVIATION 6.4 • n=42 Participants
|
55.7 Years
STANDARD_DEVIATION 12.7 • n=42 Participants
|
54.1 Years
STANDARD_DEVIATION 10.9 • n=36 Participants
|
56.2 Years
STANDARD_DEVIATION 12.4 • n=36 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
36 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
41 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
8 Participants
n=36 Participants
|
72 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (Up to 21 days)Population: All participants that have received one dose of study treatment
A DLT was any of the following deemed drug related by investigator and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 criteria: Grade (G)4 hematologic toxicity lasting ≥7 days; G4 thrombocytopenia; G3 or 4 febrile neutropenia and/or infection requiring treatment; G3, 4, 5 non-hematologic toxicity(with the exception of G3 nausea, vomiting, diarrhea, dehydration, or hyperglycemia that as a result of inadequate compliance with supportive care measures; alopecia, inadequately treated hypersensitivity reactions G3 elevated transaminases of ≤1 week in duration); adverse experience (AE) leading to dose reduction; unresolved toxicity causing ≥3 week delay in treatment; ≥G3 hyperglycemia; persistent increases in QTc interval; clinically significant bradycardia; and missing MK-2206 doses due to toxicity. The number of participants who experienced a DLT is presented.
Outcome measures
| Measure |
MK-2206 45 mg QOD+Carboplatin+Paclitaxel
n=6 Participants
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 60 mg QOD+Carboplatin+Paclitaxel
n=9 Participants
Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 90 mg Q3W+Carboplatin+Paclitaxel
n=5 Participants
Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 135 mg Q3W+Carboplatin+Paclitaxel
n=5 Participants
Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 200 mg Q3W+Carboplatin+Paclitaxel
n=6 Participants
Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 45 mg QOD+Docetaxel 75 mg/m^2
n=5 Participants
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 90 mg Q3W+Docetaxel 60 mg/m^2
n=3 Participants
Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 135 mg Q3W+Docetaxel 60 mg/m^2
n=4 Participants
Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 200 mg Q3W+Docetaxel 60 mg/m^2
n=4 Participants
Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 45 mg QOD+Erlotinib 100 mg
n=9 Participants
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 45 mg QOD+Erlotinib 150 mg
n=4 Participants
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 100 mg
n=6 Participants
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 150 mg
n=6 Participants
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (Up to 21 days)Population: All participants who received MK-2206 QOD+carboplatin+paclitaxel and had a DLT in Cycle 1 or received 90% of the planned doses and completed all safety evaluations ≤21 days after the first administration of treatment without experiencing a DLT. MTD could not be determined according to pre-defined protocol criteria based on the enrollment number.
Participants received MK-2206 (45 or 60 mg) administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle. The MTD was determined by the number of participants who experienced a dose limiting toxicity (DLT). DLT was defined using the NCI CTCAE version 3.0 criteria. See primary DLT outcome measure for the DLT definition. The MTD was defined as the dose level, at which the percentage of patients who experienced a DLT rate in Cycle 1 that was closest to 30%. A minimum of 13 participants were required to be enrolled per dose to calculate DLT. If the DLT threshold or enrollment quota per dose were not reached then the MTD could not be determined.
Outcome measures
| Measure |
MK-2206 45 mg QOD+Carboplatin+Paclitaxel
n=9 Participants
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 60 mg QOD+Carboplatin+Paclitaxel
Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 90 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 135 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 200 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 45 mg QOD+Docetaxel 75 mg/m^2
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 90 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 135 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 200 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 45 mg QOD+Erlotinib 100 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 45 mg QOD+Erlotinib 150 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 100 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 150 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of MK-2206 Administered Every Other Day (QOD) in Combination With Carboplatin and Paclitaxel
|
NA mg
MTD could not be determined
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 (up to 21 days)Population: All participants who received MK-2206 Q3W+carboplatin+paclitaxel and had a DLT in Cycle 1 or received 90% of the planned doses and completed all safety evaluations ≤21 days after the first administration of treatment without experiencing a DLT. MTD could not be determined according to pre-defined protocol criteria based on the enrollment number.
Participants received MK-2206 (90, 135, or 200 mg) administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle. The MTD was determined by the number of participants who experienced a DLT. DLT was defined using the NCI CTCAE version 3.0 criteria. See primary DLT outcome measure for the DLT definition. The MTD was defined as the dose level, at which the percentage of patients who experienced a DLT rate in Cycle 1 that was closest to 30%. A minimum of 13 participants were required to be enrolled per dose to calculate DLT. If the DLT threshold or enrollment quota per dose were not reached then the MTD could not be determined.
Outcome measures
| Measure |
MK-2206 45 mg QOD+Carboplatin+Paclitaxel
n=15 Participants
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 60 mg QOD+Carboplatin+Paclitaxel
Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 90 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 135 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 200 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 45 mg QOD+Docetaxel 75 mg/m^2
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 90 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 135 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 200 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 45 mg QOD+Erlotinib 100 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 45 mg QOD+Erlotinib 150 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 100 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 150 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
MTD of MK-2206 Administered Every Three Weeks (Q3W) in Combination With Carboplatin and Paclitaxel
|
NA mg
MTD could not be determined
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 (up to 21 days)Population: All participants who received MK-2206 QOD+docetaxel and had a DLT in Cycle 1 or received 90% of the planned doses and completed all safety evaluations ≤21 days after the first administration of treatment without experiencing a DLT. MTD could not be determined according to pre-defined protocol criteria based on the enrollment number.
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily. The MTD was determined by the number of participants who experienced a DLT. DLT was defined using the NCI CTCAE version 3.0 criteria. See primary DLT outcome measure for the DLT definition. The MTD was defined as the dose level, at which the percentage of patients who experienced a DLT rate in Cycle 1 that was closest to 30%. A minimum of 13 participants were required to be enrolled per dose to calculate DLT. If the DLT threshold or enrollment quota per dose were not reached then the MTD could not be determined.
Outcome measures
| Measure |
MK-2206 45 mg QOD+Carboplatin+Paclitaxel
n=5 Participants
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 60 mg QOD+Carboplatin+Paclitaxel
Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 90 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 135 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 200 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 45 mg QOD+Docetaxel 75 mg/m^2
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 90 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 135 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 200 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 45 mg QOD+Erlotinib 100 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 45 mg QOD+Erlotinib 150 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 100 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 150 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
MTD of MK-2206 Administered QOD in Combination With Docetaxel
|
NA mg
MTD could not be determined
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 (up to 21 days)Population: All participants who received MK-2206 Q3W+docetaxel and had a DLT in Cycle 1 or received 90% of the planned doses and completed all safety evaluations ≤21 days after the first administration of treatment without experiencing a DLT. MTD could not be determined according to pre-defined protocol criteria based on the enrollment number.
Participants received MK-2206 (90, 135, or 200 mg) administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily. The MTD was determined by the number of participants who experienced a DLT. DLT was defined using the NCI CTCAE version 3.0 criteria. See primary DLT outcome measure for the DLT definition. The MTD was defined as the dose level, at which the percentage of patients who experienced a DLT rate in Cycle 1 that was closest to 30%. A minimum of 13 participants were required to be enrolled per dose to calculate DLT. If the DLT threshold or enrollment quota per dose were not reached then the MTD could not be determined.
Outcome measures
| Measure |
MK-2206 45 mg QOD+Carboplatin+Paclitaxel
n=10 Participants
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 60 mg QOD+Carboplatin+Paclitaxel
Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 90 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 135 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 200 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 45 mg QOD+Docetaxel 75 mg/m^2
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 90 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 135 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 200 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 45 mg QOD+Erlotinib 100 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 45 mg QOD+Erlotinib 150 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 100 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 150 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
MTD of MK-2206 Administered Q3W in Combination With Docetaxel
|
NA mg
MTD could not be determined
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 (up to 21 days)Population: All participants who received MK-2206 QOD+erlotinib and had a DLT in Cycle 1 or received 90% of the planned doses and completed all safety evaluations ≤21 days after the first administration of treatment without experiencing a DLT. MTD could not be determined according to pre-defined protocol criteria based on the enrollment number.
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib (100 or 150 mg) administered PO once every day of each 21-day cycle. The MTD was determined by the number of participants who experienced a DLT. DLT was defined using the NCI CTCAE version 3.0 criteria. See primary DLT outcome measure for the DLT definition. The MTD was defined as the dose level, at which the percentage of patients who experienced a DLT rate in Cycle 1 that was closest to 30%. A minimum of 13 participants were required to be enrolled per dose to calculate DLT. If the DLT threshold or enrollment quota per dose were not reached then the MTD could not be determined.
Outcome measures
| Measure |
MK-2206 45 mg QOD+Carboplatin+Paclitaxel
n=11 Participants
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 60 mg QOD+Carboplatin+Paclitaxel
Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 90 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 135 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 200 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 45 mg QOD+Docetaxel 75 mg/m^2
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 90 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 135 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 200 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 45 mg QOD+Erlotinib 100 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 45 mg QOD+Erlotinib 150 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 100 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 150 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
MTD of MK-2206 Administered QOD in Combination With Erlotinib
|
NA mg
MTD could not be determined
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 (up to 21 days)Population: All participants who received MK-2206 QW+erlotinib and had a DLT in Cycle 1 or received 90% of the planned doses and completed all safety evaluations ≤21 days after the first administration of treatment without experiencing a DLT. MTD could not be determined according to pre-defined protocol criteria based on the enrollment number.
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib (100 or 150 mg) administered PO once every day of each 21-day cycle. The MTD was determined by the number of participants who experienced a DLT. DLT was defined using the NCI CTCAE version 3.0 criteria. See primary DLT outcome measure for the DLT definition. The MTD was defined as the dose level, at which the percentage of patients who experienced a DLT rate in Cycle 1 that was closest to 30%. A minimum of 13 participants were required to be enrolled per dose to calculate DLT. If the DLT threshold or enrollment quota per dose were not reached then the MTD could not be determined.
Outcome measures
| Measure |
MK-2206 45 mg QOD+Carboplatin+Paclitaxel
n=9 Participants
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 60 mg QOD+Carboplatin+Paclitaxel
Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 90 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 135 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 200 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 45 mg QOD+Docetaxel 75 mg/m^2
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 90 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 135 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 200 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 45 mg QOD+Erlotinib 100 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 45 mg QOD+Erlotinib 150 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 100 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 150 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
MTD of MK-2206 Administered Once Every Week (QW) in Combination With Erlotinib
|
NA mg
MTD could not be determined
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At designated time points on Cycle 1 Day 1 (Up to 96 hours)Population: All participants who received MK-2206 on Cycle 1 Day 1 and had blood samples drawn for the PK parameter being analyzed
Blood samples are to be collected at specified time points according to arm and schedule: QOD schedule for MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48 hours(h) postdose); Q3W schedule MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48, 96h postdose); QOD schedule for the MK-2206+erlotinib (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose); and QW schedule for MK-2206+erlotinib (Cycles 1 Day 1: predose and 2, 4, 6, 10, 24, 48, 96h postdose) for the determination of MK-2206 Cmax after Dose 1. The Cmax of MK-2206 after Dose 1 will be presented.
Outcome measures
| Measure |
MK-2206 45 mg QOD+Carboplatin+Paclitaxel
n=6 Participants
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 60 mg QOD+Carboplatin+Paclitaxel
n=8 Participants
Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 90 mg Q3W+Carboplatin+Paclitaxel
n=5 Participants
Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 135 mg Q3W+Carboplatin+Paclitaxel
n=5 Participants
Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 200 mg Q3W+Carboplatin+Paclitaxel
n=6 Participants
Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 45 mg QOD+Docetaxel 75 mg/m^2
n=5 Participants
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 90 mg Q3W+Docetaxel 60 mg/m^2
n=3 Participants
Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 135 mg Q3W+Docetaxel 60 mg/m^2
n=3 Participants
Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 200 mg Q3W+Docetaxel 60 mg/m^2
n=4 Participants
Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 45 mg QOD+Erlotinib 100 mg
n=9 Participants
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 45 mg QOD+Erlotinib 150 mg
n=4 Participants
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 100 mg
n=6 Participants
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 150 mg
n=6 Participants
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration of MK-2206 (Cmax)
|
57.7 nmol/L
Standard Deviation 13.8
|
88.3 nmol/L
Standard Deviation 24.2
|
144 nmol/L
Standard Deviation 57.0
|
247 nmol/L
Standard Deviation 52.5
|
431 nmol/L
Standard Deviation 249
|
42.9 nmol/L
Standard Deviation 13.3
|
106 nmol/L
Standard Deviation 42.5
|
278 nmol/L
Standard Deviation 35.5
|
287 nmol/L
Standard Deviation 67.6
|
48.8 nmol/L
Standard Deviation 11.2
|
65.6 nmol/L
Standard Deviation 29.3
|
212 nmol/L
Standard Deviation 75.9
|
244 nmol/L
Standard Deviation 84.2
|
PRIMARY outcome
Timeframe: At designated time points on Cycle 1 Day 1 (Up to 96 hours)Population: All participants who received MK-2206 on Cycle 1 Day 1 and had blood samples drawn for the PK parameter being analyzed
Blood samples are to be collected at specified time points according to arm and schedule: QOD schedule for MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48 hours(h) postdose); Q3W schedule MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48, 96h postdose); QOD schedule for the MK-2206+erlotinib (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose); and QW schedule for MK-2206+erlotinib (Cycles 1 Day 1: predose and 2, 4, 6, 10, 24, 48, 96h postdose) for the determination of MK-2206 Tmax after Dose 1. The Tmax of MK-2206 after Dose 1 will be presented.
Outcome measures
| Measure |
MK-2206 45 mg QOD+Carboplatin+Paclitaxel
n=6 Participants
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 60 mg QOD+Carboplatin+Paclitaxel
n=8 Participants
Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 90 mg Q3W+Carboplatin+Paclitaxel
n=5 Participants
Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 135 mg Q3W+Carboplatin+Paclitaxel
n=5 Participants
Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 200 mg Q3W+Carboplatin+Paclitaxel
n=6 Participants
Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 45 mg QOD+Docetaxel 75 mg/m^2
n=5 Participants
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 90 mg Q3W+Docetaxel 60 mg/m^2
n=3 Participants
Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 135 mg Q3W+Docetaxel 60 mg/m^2
n=3 Participants
Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 200 mg Q3W+Docetaxel 60 mg/m^2
n=4 Participants
Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 45 mg QOD+Erlotinib 100 mg
n=9 Participants
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 45 mg QOD+Erlotinib 150 mg
n=4 Participants
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 100 mg
n=6 Participants
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 150 mg
n=6 Participants
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration of MK-2206 (Tmax)
|
4.0 hours
Interval 4.0 to 6.0
|
8.0 hours
Interval 6.0 to 10.0
|
6.0 hours
Interval 4.0 to 10.0
|
10.0 hours
Interval 6.0 to 10.0
|
5.0 hours
Interval 4.0 to 10.0
|
6.0 hours
Interval 4.0 to 10.0
|
4.0 hours
Interval 4.0 to 10.0
|
6.0 hours
Interval 4.0 to 10.0
|
6.0 hours
Interval 4.0 to 6.0
|
6.0 hours
Interval 4.0 to 10.0
|
7.0 hours
Interval 4.0 to 24.0
|
6.0 hours
Interval 2.0 to 6.0
|
4.0 hours
Interval 4.0 to 10.0
|
PRIMARY outcome
Timeframe: At designated time points on Cycle 1 Day 1 (Up to 48 hours)Population: All participants who received MK-2206 on Cycle 1 Day 1 and had blood samples drawn for the PK parameter being analyzed
Blood samples are to be collected at specified time points according to arm and schedule: QOD schedule for MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48 hours(h) postdose); Q3W schedule MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose); QOD schedule for the MK-2206+erlotinib (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose); and QW schedule for MK-2206+erlotinib (Cycles 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose) for the determination of MK-2206 Ctrough after Dose 1. The Ctrough after Dose 1 is presented and is the 48-hour postdose concentration.
Outcome measures
| Measure |
MK-2206 45 mg QOD+Carboplatin+Paclitaxel
n=6 Participants
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 60 mg QOD+Carboplatin+Paclitaxel
n=8 Participants
Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 90 mg Q3W+Carboplatin+Paclitaxel
n=5 Participants
Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 135 mg Q3W+Carboplatin+Paclitaxel
n=5 Participants
Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 200 mg Q3W+Carboplatin+Paclitaxel
n=6 Participants
Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 45 mg QOD+Docetaxel 75 mg/m^2
n=5 Participants
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 90 mg Q3W+Docetaxel 60 mg/m^2
n=3 Participants
Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 135 mg Q3W+Docetaxel 60 mg/m^2
n=1 Participants
Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 200 mg Q3W+Docetaxel 60 mg/m^2
n=4 Participants
Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 45 mg QOD+Erlotinib 100 mg
n=9 Participants
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 45 mg QOD+Erlotinib 150 mg
n=4 Participants
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 100 mg
n=6 Participants
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 150 mg
n=6 Participants
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Minimum Plasma Concentration of MK-2206 (Ctrough)
|
24.9 nmol/L
Standard Deviation 10.7
|
40.6 nmol/L
Standard Deviation 11.2
|
1.36 nmol/L
Standard Deviation 0.898
|
4.67 nmol/L
Standard Deviation 3.33
|
2.21 nmol/L
Standard Deviation 1.04
|
17.1 nmol/L
Standard Deviation 3.66
|
2.27 nmol/L
Standard Deviation 1.04
|
3.80 nmol/L
Standard Deviation NA
Standard deviation could not be calculated for 1 participant
|
3.24 nmol/L
Standard Deviation 0.638
|
23.8 nmol/L
Standard Deviation 8.12
|
36.8 nmol/L
Standard Deviation 10.6
|
96.6 nmol/L
Standard Deviation 43.6
|
95.5 nmol/L
Standard Deviation 43.1
|
PRIMARY outcome
Timeframe: At designated time points on Cycle 1 Day 1 (Up to 48 hours)Population: All participants who received MK-2206 on Cycle 1 Day 1 and had blood samples drawn for the PK parameter being analyzed
Blood samples are to be collected at specified time points according to arm and schedule: QOD schedule for MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48 hours(h) postdose); Q3W schedule MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose); QOD schedule for the MK-2206+erlotinib (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose); and QW schedule for MK-2206+erlotinib (Cycles 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose) for the determination of MK-2206 AUC0-48h after Dose 1. The AUC0-48h after Dose 1 is presented.
Outcome measures
| Measure |
MK-2206 45 mg QOD+Carboplatin+Paclitaxel
n=6 Participants
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 60 mg QOD+Carboplatin+Paclitaxel
n=8 Participants
Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 90 mg Q3W+Carboplatin+Paclitaxel
n=5 Participants
Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 135 mg Q3W+Carboplatin+Paclitaxel
n=5 Participants
Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 200 mg Q3W+Carboplatin+Paclitaxel
n=6 Participants
Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 45 mg QOD+Docetaxel 75 mg/m^2
n=5 Participants
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 90 mg Q3W+Docetaxel 60 mg/m^2
n=3 Participants
Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 135 mg Q3W+Docetaxel 60 mg/m^2
n=3 Participants
Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 200 mg Q3W+Docetaxel 60 mg/m^2
n=4 Participants
Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 45 mg QOD+Erlotinib 100 mg
n=9 Participants
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 45 mg QOD+Erlotinib 150 mg
n=4 Participants
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 100 mg
n=6 Participants
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 150 mg
n=6 Participants
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the MK-2206 Concentration Versus Time Curve From Time Zero to 48 Hours Postdose (AUC 0-48h)
|
1630 nmol•hr/L
Standard Deviation 496
|
2700 nmol•hr/L
Standard Deviation 619
|
4130 nmol•hr/L
Standard Deviation 1520
|
7420 nmol•hr/L
Standard Deviation 1250
|
9730 nmol•hr/L
Standard Deviation 2320
|
1320 nmol•hr/L
Standard Deviation 395
|
3000 nmol•hr/L
Standard Deviation 1250
|
8090 nmol•hr/L
Standard Deviation 542
|
7690 nmol•hr/L
Standard Deviation 1550
|
1460 nmol•hr/L
Standard Deviation 417
|
2110 nmol•hr/L
Standard Deviation 637
|
6420 nmol•hr/L
Standard Deviation 2760
|
6560 nmol•hr/L
Standard Deviation 2650
|
SECONDARY outcome
Timeframe: Up to approximately 4 months (6 cycles)Population: All participants who received at least one dose of study treatment and had measurable disease at baseline.
Tumor response was assessed using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) and was recorded from the start of the study treatment until the end of treatment. Response categories included: Complete Response (CR): disappearance of all target lesions and Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions. The number of participants who had a tumor response of either CR or PR is presented.
Outcome measures
| Measure |
MK-2206 45 mg QOD+Carboplatin+Paclitaxel
n=6 Participants
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 60 mg QOD+Carboplatin+Paclitaxel
n=9 Participants
Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 90 mg Q3W+Carboplatin+Paclitaxel
n=5 Participants
Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 135 mg Q3W+Carboplatin+Paclitaxel
n=5 Participants
Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 200 mg Q3W+Carboplatin+Paclitaxel
n=6 Participants
Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 45 mg QOD+Docetaxel 75 mg/m^2
n=5 Participants
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 90 mg Q3W+Docetaxel 60 mg/m^2
n=3 Participants
Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 135 mg Q3W+Docetaxel 60 mg/m^2
n=4 Participants
Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 200 mg Q3W+Docetaxel 60 mg/m^2
n=4 Participants
Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 45 mg QOD+Erlotinib 100 mg
n=9 Participants
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 45 mg QOD+Erlotinib 150 mg
n=4 Participants
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 100 mg
n=6 Participants
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 150 mg
n=6 Participants
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Had a Tumor Response of Complete Response (CR) or Partial Response (PR)
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
MK-2206 45 mg QOD+Carboplatin+Paclitaxel
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
MK-2206 60 mg QOD+Carboplatin+Paclitaxel
Serious events: 8 serious events
Other events: 8 other events
Deaths: 1 deaths
MK-2206 90 mg Q3W+Carboplatin+Paclitaxel
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
MK-2206 135 mg Q3W+Carboplatin+Paclitaxel
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
MK-2206 200 mg Q3W+Carboplatin+Paclitaxel
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
MK-2206 45 mg QOD+Docetaxel 75 mg/m2
Serious events: 5 serious events
Other events: 5 other events
Deaths: 1 deaths
MK-2206 90 mg Q3W+Docetaxel 60 mg/m2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
MK-2206 135 mg Q3W+Docetaxel 60 mg/m2
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
MK-2206 200 mg Q3W+Docetaxel 60 mg/m2
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
MK-2206 45 mg QOD+Erlotinib 100 mg
Serious events: 6 serious events
Other events: 9 other events
Deaths: 1 deaths
MK-2206 45 mg QOD+Erlotinib 150 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
MK-2206 135 mg QW+Erlotinib 100 mg
Serious events: 4 serious events
Other events: 6 other events
Deaths: 1 deaths
MK-2206 135 mg QW+Erlotinib 150 mg
Serious events: 5 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
MK-2206 45 mg QOD+Carboplatin+Paclitaxel
n=6 participants at risk
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 60 mg QOD+Carboplatin+Paclitaxel
n=9 participants at risk
Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 90 mg Q3W+Carboplatin+Paclitaxel
n=5 participants at risk
Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 135 mg Q3W+Carboplatin+Paclitaxel
n=5 participants at risk
Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 200 mg Q3W+Carboplatin+Paclitaxel
n=6 participants at risk
Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 45 mg QOD+Docetaxel 75 mg/m2
n=5 participants at risk
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 90 mg Q3W+Docetaxel 60 mg/m2
n=3 participants at risk
Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 135 mg Q3W+Docetaxel 60 mg/m2
n=4 participants at risk
Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 200 mg Q3W+Docetaxel 60 mg/m2
n=4 participants at risk
Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 45 mg QOD+Erlotinib 100 mg
n=9 participants at risk
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 45 mg QOD+Erlotinib 150 mg
n=4 participants at risk
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 100 mg
n=6 participants at risk
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 150 mg
n=6 participants at risk
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
22.2%
2/9 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
22.2%
2/9 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
60.0%
3/5 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
1/3 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
General disorders
Fatigue
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Infections and infestations
Infection
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Investigations
Transaminases increased
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
Other adverse events
| Measure |
MK-2206 45 mg QOD+Carboplatin+Paclitaxel
n=6 participants at risk
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 60 mg QOD+Carboplatin+Paclitaxel
n=9 participants at risk
Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 90 mg Q3W+Carboplatin+Paclitaxel
n=5 participants at risk
Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 135 mg Q3W+Carboplatin+Paclitaxel
n=5 participants at risk
Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 200 mg Q3W+Carboplatin+Paclitaxel
n=6 participants at risk
Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m\^2 administered IV on Day 1 of each 21-day cycle.
|
MK-2206 45 mg QOD+Docetaxel 75 mg/m2
n=5 participants at risk
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 90 mg Q3W+Docetaxel 60 mg/m2
n=3 participants at risk
Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 135 mg Q3W+Docetaxel 60 mg/m2
n=4 participants at risk
Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 200 mg Q3W+Docetaxel 60 mg/m2
n=4 participants at risk
Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m\^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
|
MK-2206 45 mg QOD+Erlotinib 100 mg
n=9 participants at risk
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 45 mg QOD+Erlotinib 150 mg
n=4 participants at risk
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 100 mg
n=6 participants at risk
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
|
MK-2206 135 mg QW+Erlotinib 150 mg
n=6 participants at risk
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
1/3 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
50.0%
3/6 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
44.4%
4/9 • Number of events 6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
66.7%
2/3 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
50.0%
2/4 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
55.6%
5/9 • Number of events 7 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
75.0%
3/4 • Number of events 5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
66.7%
4/6 • Number of events 6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
83.3%
5/6 • Number of events 7 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
55.6%
5/9 • Number of events 11 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
60.0%
3/5 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
60.0%
3/5 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 7 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
50.0%
3/6 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Blood and lymphatic system disorders
Leukopenia
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
66.7%
6/9 • Number of events 23 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
80.0%
4/5 • Number of events 9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
80.0%
4/5 • Number of events 4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
1/3 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
3/9 • Number of events 12 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 7 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
55.6%
5/9 • Number of events 13 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
80.0%
4/5 • Number of events 13 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
60.0%
3/5 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
60.0%
3/5 • Number of events 8 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
66.7%
2/3 • Number of events 6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
55.6%
5/9 • Number of events 10 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
60.0%
3/5 • Number of events 6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 7 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
1/3 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Ear and labyrinth disorders
Hyperacusis
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
22.2%
2/9 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
1/3 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Eye disorders
Diplopia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Eye disorders
Eye irritation
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Eye disorders
Lacrimation increased
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Eye disorders
Orbital oedema
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Eye disorders
Photophobia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Eye disorders
Vision blurred
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Eye disorders
Visual impairment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
22.2%
2/9 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
1/3 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Number of events 4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
66.7%
6/9 • Number of events 6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
60.0%
3/5 • Number of events 4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
66.7%
4/6 • Number of events 6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
1/3 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
50.0%
2/4 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
3/9 • Number of events 5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
100.0%
4/4 • Number of events 4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
1/3 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Post-tussive vomiting
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Steatorrhoea
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
22.2%
2/9 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
44.4%
4/9 • Number of events 6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
66.7%
4/6 • Number of events 11 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
50.0%
3/6 • Number of events 4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Toothache
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
3/9 • Number of events 4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
60.0%
3/5 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
66.7%
4/6 • Number of events 5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
60.0%
3/5 • Number of events 4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
1/3 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
44.4%
4/9 • Number of events 5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
General disorders
Application site erythema
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
General disorders
Asthenia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
1/3 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
General disorders
Catheter site swelling
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
General disorders
Chest discomfort
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
General disorders
Chest pain
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
General disorders
Chills
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
General disorders
Early satiety
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
General disorders
Fatigue
|
66.7%
4/6 • Number of events 5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
66.7%
6/9 • Number of events 7 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
80.0%
4/5 • Number of events 8 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
100.0%
5/5 • Number of events 5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
80.0%
4/5 • Number of events 4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
100.0%
3/3 • Number of events 4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
50.0%
2/4 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
100.0%
4/4 • Number of events 4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
55.6%
5/9 • Number of events 5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
75.0%
3/4 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
50.0%
3/6 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
66.7%
4/6 • Number of events 5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
General disorders
Malaise
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
General disorders
Mucosal inflammation
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
General disorders
Oedema
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
General disorders
Oedema peripheral
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
1/3 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
22.2%
2/9 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
General disorders
Pain
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
General disorders
Pyrexia
|
33.3%
2/6 • Number of events 4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
3/9 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
22.2%
2/9 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
50.0%
3/6 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
General disorders
Thirst
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
General disorders
Ulcer
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Infections and infestations
Candidiasis
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Infections and infestations
Folliculitis
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Infections and infestations
Infection
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Infections and infestations
Laryngitis
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
22.2%
2/9 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Infections and infestations
Paronychia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Infections and infestations
Sinusitis
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Infections and infestations
Viral infection
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Infections and infestations
Wound infection
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
22.2%
2/9 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Ear abrasion
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
22.2%
2/9 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
60.0%
3/5 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Investigations
Blood calcium decreased
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
22.2%
2/9 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Investigations
Blood potassium decreased
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Investigations
Blood sodium decreased
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Investigations
International normalised ratio increased
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Investigations
Liver function test abnormal
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Investigations
Neutrophil count increased
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Investigations
Transaminases increased
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Investigations
Weight decreased
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
3/9 • Number of events 4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
2/6 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
55.6%
5/9 • Number of events 6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
60.0%
3/5 • Number of events 4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
50.0%
2/4 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
22.2%
2/9 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
100.0%
4/4 • Number of events 4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
66.7%
4/6 • Number of events 5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
80.0%
4/5 • Number of events 4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
1/3 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
3/9 • Number of events 4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
60.0%
3/5 • Number of events 5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
60.0%
3/5 • Number of events 8 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
66.7%
2/3 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
3/9 • Number of events 5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
3/9 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
60.0%
3/5 • Number of events 5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
22.2%
2/9 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
44.4%
4/9 • Number of events 4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
22.2%
2/9 • Number of events 4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
3/9 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
3/9 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
2/6 • Number of events 4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
3/9 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
33.3%
2/6 • Number of events 4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
22.2%
2/9 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
60.0%
3/5 • Number of events 6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
22.2%
2/9 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
50.0%
3/6 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
1/3 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
1/3 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
22.2%
2/9 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Nervous system disorders
Akathisia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Nervous system disorders
Ataxia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
1/3 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
50.0%
2/4 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
1/3 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
3/9 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
22.2%
2/9 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
66.7%
2/3 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
50.0%
2/4 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Nervous system disorders
Migraine
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Nervous system disorders
Multifocal motor neuropathy
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
44.4%
4/9 • Number of events 4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
80.0%
4/5 • Number of events 5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
60.0%
3/5 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
2/6 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Nervous system disorders
Syncope
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Nervous system disorders
Tonic convulsion
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Psychiatric disorders
Agitation
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
22.2%
2/9 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Renal and urinary disorders
Urogenital fistula
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
44.4%
4/9 • Number of events 4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
22.2%
2/9 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
50.0%
3/6 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
3/9 • Number of events 4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
83.3%
5/6 • Number of events 5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
1/3 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
66.7%
4/6 • Number of events 6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
66.7%
6/9 • Number of events 7 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
100.0%
5/5 • Number of events 5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
80.0%
4/5 • Number of events 4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
60.0%
3/5 • Number of events 4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
1/3 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
50.0%
2/4 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
1/3 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
1/3 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
22.2%
2/9 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
50.0%
3/6 • Number of events 6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
50.0%
3/6 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
66.7%
4/6 • Number of events 5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
40.0%
2/5 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
3/9 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
50.0%
3/6 • Number of events 7 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
66.7%
4/6 • Number of events 6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
22.2%
2/9 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
80.0%
4/5 • Number of events 6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
66.7%
2/3 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
55.6%
5/9 • Number of events 7 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
75.0%
3/4 • Number of events 5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
66.7%
4/6 • Number of events 12 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
66.7%
4/6 • Number of events 6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Rash follicular
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
20.0%
1/5 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
22.2%
2/9 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Vascular disorders
Angiopathy
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
25.0%
1/4 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Vascular disorders
Hot flush
|
33.3%
2/6 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
33.3%
1/3 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
11.1%
1/9 • Number of events 2 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/5 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/3 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/9 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/4 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
0.00%
0/6 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
16.7%
1/6 • Number of events 1 • Up to approximately 14 months (Up to 30 days after last dose of study treatment)
All participants who received at least one dose of study treatment
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER