Trial Outcomes & Findings for Study of Safety and Pharmacokinetics of MK-8242 in Participants With Advanced Solid Tumors (P07650) (NCT NCT01463696)
NCT ID: NCT01463696
Last Updated: 2018-08-27
Results Overview
DLT was defined as: any drug-related hematologic toxicity ≥ Grade 3 lasting ≥1 week, ≥ Grade 3 thrombocytopenia with bleeding, ≥ Grade 3 neutropenia with infection OR non-hematologic DLTs that were any Grade 3, 4, or 5 toxicity with the following exceptions/clarifications: 1) Grade 3 nausea, vomiting, diarrhea, and dehydration were excluded from the determination of DLT if, in the opinion of the investigator and sponsor, they occurred in a setting of inadequate treatment, 2) Grade 3 nausea, vomiting, diarrhea, and dehydration were each considered a DLT if they persisted despite 72 hours of maximal supportive care measures or 3) Any abnormal non-hematological laboratory value ≥ Grade 3 (that is not attributable to any other causes) was considered a DLT only if medical intervention was required to treat the participant, the abnormality led to hospitalization, or the abnormality persisted for ≥1 week.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Cycle 1 (21 days)
Results posted on
2018-08-27
Participant Flow
Participant milestones
| Measure |
MK-8242 60 mg BID
In Cycle 1, participants received MK-8242 60 mg administered orally (PO) twice a day (BID) on Days 1-6 and PO once daily (QD) in the morning on Day 7 of the 21-day cycle to accommodate pharmacokinetic (PK) sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 120 mg BID
In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 170 mg BID
In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 250 mg BID
In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 300 mg BID
In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 350 mg BID
In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 400 mg BID
In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 500 mg BID
In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
6
|
3
|
7
|
3
|
6
|
16
|
6
|
|
Overall Study
Treated
|
1
|
6
|
3
|
7
|
3
|
6
|
15
|
6
|
|
Overall Study
COMPLETED
|
1
|
4
|
2
|
3
|
2
|
3
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
1
|
4
|
1
|
3
|
10
|
4
|
Reasons for withdrawal
| Measure |
MK-8242 60 mg BID
In Cycle 1, participants received MK-8242 60 mg administered orally (PO) twice a day (BID) on Days 1-6 and PO once daily (QD) in the morning on Day 7 of the 21-day cycle to accommodate pharmacokinetic (PK) sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 120 mg BID
In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 170 mg BID
In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 250 mg BID
In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 300 mg BID
In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 350 mg BID
In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 400 mg BID
In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 500 mg BID
In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
2
|
0
|
1
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Progressive Disease
|
0
|
1
|
0
|
1
|
0
|
1
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
1
|
1
|
2
|
0
|
|
Overall Study
Not Treated
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study of Safety and Pharmacokinetics of MK-8242 in Participants With Advanced Solid Tumors (P07650)
Baseline characteristics by cohort
| Measure |
MK-8242 60 mg BID
n=1 Participants
In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 120 mg BID
n=6 Participants
In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 170 mg BID
n=3 Participants
In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 250 mg BID
n=7 Participants
In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 300 mg BID
n=3 Participants
In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 350 mg BID
n=6 Participants
In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 400 mg BID
n=16 Participants
In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 500 mg BID
n=6 Participants
In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
47.0 Years
STANDARD_DEVIATION NA • n=99 Participants
|
60.0 Years
STANDARD_DEVIATION 11.0 • n=107 Participants
|
68.3 Years
STANDARD_DEVIATION 7.4 • n=206 Participants
|
60.3 Years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
53.3 Years
STANDARD_DEVIATION 12.3 • n=31 Participants
|
58.2 Years
STANDARD_DEVIATION 10.2 • n=30 Participants
|
63.9 Years
STANDARD_DEVIATION 10.4 • n=3 Participants
|
62.5 Years
STANDARD_DEVIATION 12.8 • n=6 Participants
|
61.3 Years
STANDARD_DEVIATION 10.8 • n=114 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
19 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
10 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
29 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (21 days)Population: The DLT-evaluable population consisted of participants who received at least one dose of MK-8242 and completed Cycle 1 of Part 1 (dose escalation) or the dose confirmation portion of Part 2, or discontinued due to toxicity.
DLT was defined as: any drug-related hematologic toxicity ≥ Grade 3 lasting ≥1 week, ≥ Grade 3 thrombocytopenia with bleeding, ≥ Grade 3 neutropenia with infection OR non-hematologic DLTs that were any Grade 3, 4, or 5 toxicity with the following exceptions/clarifications: 1) Grade 3 nausea, vomiting, diarrhea, and dehydration were excluded from the determination of DLT if, in the opinion of the investigator and sponsor, they occurred in a setting of inadequate treatment, 2) Grade 3 nausea, vomiting, diarrhea, and dehydration were each considered a DLT if they persisted despite 72 hours of maximal supportive care measures or 3) Any abnormal non-hematological laboratory value ≥ Grade 3 (that is not attributable to any other causes) was considered a DLT only if medical intervention was required to treat the participant, the abnormality led to hospitalization, or the abnormality persisted for ≥1 week.
Outcome measures
| Measure |
MK-8242 60 mg BID
n=1 Participants
In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 120 mg BID
n=6 Participants
In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 170 mg BID
n=3 Participants
In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 250 mg BID
n=7 Participants
In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 300 mg BID
n=3 Participants
In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 350 mg BID
n=6 Participants
In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 400 mg BID
n=15 Participants
In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 500 mg BID
n=6 Participants
In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 pre-dose and through 24 hours post dose; Cycle 1 Day 7 pre-dose and through 48 hours post dosePopulation: The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
PK plasma samples were to be collected at the following time points: 0, 0.5, 1, 2, 4, 6, 8,and 12 hours after the first dose on Day 1; and 0, 0.5, 1, 2, 4, 6, 8, 12, 24 (Day 8) and 48 (Day 9) hours post-dose on Day 7.
Outcome measures
| Measure |
MK-8242 60 mg BID
n=1 Participants
In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 120 mg BID
n=5 Participants
In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 170 mg BID
n=3 Participants
In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 250 mg BID
n=6 Participants
In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 300 mg BID
n=3 Participants
In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 350 mg BID
n=6 Participants
In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 400 mg BID
n=14 Participants
In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 500 mg BID
n=6 Participants
In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of MK-8242
Day 7 (n=1, 5, 3, 6, 3, 5, 12, 3)
|
150 nM
Geometric Coefficient of Variation NA
Only 1 participant had PK parameter assessed; no geometric coefficient of variation was calculated.
|
551 nM
Geometric Coefficient of Variation 90.1
|
1680 nM
Geometric Coefficient of Variation 30.2
|
1030 nM
Geometric Coefficient of Variation 133.7
|
1720 nM
Geometric Coefficient of Variation 89.7
|
1930 nM
Geometric Coefficient of Variation 52.4
|
3070 nM
Geometric Coefficient of Variation 38.7
|
1800 nM
Geometric Coefficient of Variation 63.0
|
|
Maximum Observed Plasma Concentration (Cmax) of MK-8242
Day 1 (n=1, 5, 3, 6, 3, 6, 14, 6)
|
162 nM
Geometric Coefficient of Variation NA
Only 1 participant had PK parameter assessed; no geometric coefficient of variation was calculated.
|
402 nM
Geometric Coefficient of Variation 101.2
|
813 nM
Geometric Coefficient of Variation 208.7
|
1210 nM
Geometric Coefficient of Variation 80.4
|
1320 nM
Geometric Coefficient of Variation 33.4
|
1510 nM
Geometric Coefficient of Variation 166.2
|
3820 nM
Geometric Coefficient of Variation 39.4
|
4240 nM
Geometric Coefficient of Variation 45.5
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 pre-dose and through 12 hours postdose; Cycle 1 Day 7 pre-dose and through 48 hours post dosePopulation: The APaT population consisted of all participants who received at least one dose of study drug.
PK plasma samples were to be collected at the following time points: 0, 0.5, 1, 2, 4, 6, 8 and 12 hours after the first dose on Day 1; and 0, 0.5, 1, 2, 4, 6, 8, 12, 24 (Day 8) and 48 (Day 9) hours post-dose on Day 7.
Outcome measures
| Measure |
MK-8242 60 mg BID
n=1 Participants
In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 120 mg BID
n=5 Participants
In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 170 mg BID
n=3 Participants
In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 250 mg BID
n=6 Participants
In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 300 mg BID
n=3 Participants
In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 350 mg BID
n=6 Participants
In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 400 mg BID
n=14 Participants
In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 500 mg BID
n=6 Participants
In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of MK-8242
Day 1 (n=1, 5, 3, 6, 3, 6, 14, 6)
|
2.03 Hours
Only 1 participant had PK parameter assessed; no full range was calculated.
|
2.07 Hours
Interval 1.95 to 6.08
|
4.30 Hours
Interval 2.0 to 6.0
|
4.00 Hours
Interval 2.0 to 4.27
|
2.18 Hours
Interval 2.0 to 2.23
|
4.04 Hours
Interval 2.0 to 4.08
|
2.00 Hours
Interval 1.0 to 11.47
|
3.04 Hours
Interval 2.0 to 8.0
|
|
Time to Maximum Plasma Concentration (Tmax) of MK-8242
Day 7 (n=1, 5, 3, 6, 3, 5, 12, 3)
|
1.98 Hours
Only 1 participant had PK parameter assessed; no full range was calculated.
|
4.00 Hours
Interval 1.88 to 6.08
|
2.00 Hours
Interval 2.0 to 4.0
|
3.23 Hours
Interval 2.0 to 11.97
|
2.00 Hours
Interval 2.0 to 2.0
|
4.00 Hours
Interval 2.0 to 5.97
|
3.03 Hours
Interval 2.0 to 6.92
|
2.08 Hours
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 and Day 7, Hour 0 through Hour 12Population: The APaT population consisted of all participants who received at least one dose of study drug.
PK plasma samples were to be collected at the following time points: 0, 0.5, 1, 2, 4, 6, 8 and 12 hours after the first dose on Day 1; and 0, 0.5, 1, 2, 4, 6, 8, 12, 24 (Day 8) and 48 (Day 9) hours post-dose on Day 7.
Outcome measures
| Measure |
MK-8242 60 mg BID
n=1 Participants
In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 120 mg BID
n=5 Participants
In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 170 mg BID
n=3 Participants
In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 250 mg BID
n=6 Participants
In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 300 mg BID
n=3 Participants
In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 350 mg BID
n=6 Participants
In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 400 mg BID
n=14 Participants
In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 500 mg BID
n=6 Participants
In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Time Curve From Hour 0 to Hour 12 (AUC0-12) for MK-8242
Day 1 (n=1, 4, 1, 3, 3, 2, 12, 4)
|
548 hr*nM
Geometric Coefficient of Variation NA
Only 1 participant had PK parameter assessed; no geometric coefficient of variation was calculated.
|
1820 hr*nM
Geometric Coefficient of Variation 51.2
|
11000 hr*nM
Geometric Coefficient of Variation NA
Only 1 participant had PK parameter assessed; no geometric coefficient of variation was calculated.
|
5550 hr*nM
Geometric Coefficient of Variation 100.1
|
5020 hr*nM
Geometric Coefficient of Variation 45.4
|
6940 hr*nM
Geometric Coefficient of Variation 110.7
|
16800 hr*nM
Geometric Coefficient of Variation 45.3
|
24100 hr*nM
Geometric Coefficient of Variation 46.0
|
|
Area Under the Concentration Time Curve From Hour 0 to Hour 12 (AUC0-12) for MK-8242
Day 7 (n=1, 5, 3, 6, 3, 4, 12, 3)
|
706 hr*nM
Geometric Coefficient of Variation NA
Only 1 participant had PK parameter assessed; no geometric coefficient of variation was calculated.
|
2450 hr*nM
Geometric Coefficient of Variation 57.9
|
7190 hr*nM
Geometric Coefficient of Variation 24.7
|
6710 hr*nM
Geometric Coefficient of Variation 130.9
|
8720 hr*nM
Geometric Coefficient of Variation 65.1
|
13100 hr*nM
Geometric Coefficient of Variation 70.2
|
16500 hr*nM
Geometric Coefficient of Variation 41.2
|
13400 hr*nM
Geometric Coefficient of Variation 77.8
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 pre-dose and through 12 hours post dose; Cycle 1 Day 7 pre-dose and through 48 hours post dosePopulation: The APaT population consisted of all participants who received at least one dose of study drug.
PK plasma samples were to be collected at the following time points: 0, 0.5, 1, 2, 4, 6, 8 and 12 hours after the first dose on Day 1; and 0, 0.5, 1, 2, 4, 6, 8, 12, 24 (Day 8) and 48 (Day 9) hours post-dose on Day 7.
Outcome measures
| Measure |
MK-8242 60 mg BID
n=1 Participants
In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 120 mg BID
n=5 Participants
In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 170 mg BID
n=3 Participants
In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 250 mg BID
n=6 Participants
In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 300 mg BID
n=3 Participants
In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 350 mg BID
n=6 Participants
In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 400 mg BID
n=14 Participants
In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 500 mg BID
n=6 Participants
In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|
|
AUC at Time of Last Sample (AUClast) for MK-8242
Day 1 (n=1, 5, 3, 6, 3, 6, 14, 6)
|
509 hr*nM
Geometric Coefficient of Variation NA
Only 1 participant had PK parameter assessed; no geometric coefficient of variation was calculated.
|
1380 hr*nM
Geometric Coefficient of Variation 72.0
|
3240 hr*nM
Geometric Coefficient of Variation 131
|
5410 hr*nM
Geometric Coefficient of Variation 69.0
|
4830 hr*nM
Geometric Coefficient of Variation 49.7
|
6350 hr*nM
Geometric Coefficient of Variation 152
|
16700 hr*nM
Geometric Coefficient of Variation 41.9
|
17400 hr*nM
Geometric Coefficient of Variation 84.7
|
|
AUC at Time of Last Sample (AUClast) for MK-8242
Day 7 (n=1, 5, 3, 6, 3, 5, 12, 3)
|
677 hr*nM
Geometric Coefficient of Variation NA
Only 1 participant had PK parameter assessed; no geometric coefficient of variation was calculated.
|
2260 hr*nM
Geometric Coefficient of Variation 65.0
|
8290 hr*nM
Geometric Coefficient of Variation 25.1
|
7590 hr*nM
Geometric Coefficient of Variation 103
|
11300 hr*nM
Geometric Coefficient of Variation 75.0
|
15100 hr*nM
Geometric Coefficient of Variation 81.1
|
21400 hr*nM
Geometric Coefficient of Variation 48.2
|
17300 hr*nM
Geometric Coefficient of Variation 90.4
|
Adverse Events
MK-8242 60 mg BID
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MK-8242 120 mg BID
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
MK-8242 170 mg BID
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MK-8242 250 mg BID
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
MK-8242 300 mg BID
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
MK-8242 350 mg BID
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
MK-8242 400 mg BID
Serious events: 5 serious events
Other events: 15 other events
Deaths: 0 deaths
MK-8242 500 mg BID
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MK-8242 60 mg BID
n=1 participants at risk
In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 120 mg BID
n=6 participants at risk
In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 170 mg BID
n=3 participants at risk
In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 250 mg BID
n=7 participants at risk
In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 300 mg BID
n=3 participants at risk
In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 350 mg BID
n=6 participants at risk
In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 400 mg BID
n=15 participants at risk
In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 500 mg BID
n=6 participants at risk
In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
MK-8242 60 mg BID
n=1 participants at risk
In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 120 mg BID
n=6 participants at risk
In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 170 mg BID
n=3 participants at risk
In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 250 mg BID
n=7 participants at risk
In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 300 mg BID
n=3 participants at risk
In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 350 mg BID
n=6 participants at risk
In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 400 mg BID
n=15 participants at risk
In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
|
MK-8242 500 mg BID
n=6 participants at risk
In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Small intestinal bacterial overgrowth
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Otitis media
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
5/15 • Number of events 5 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
13.3%
2/15 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
66.7%
10/15 • Number of events 22 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
50.0%
3/6 • Number of events 4 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
28.6%
2/7 • Number of events 6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
60.0%
9/15 • Number of events 23 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Eye disorders
Conjunctival haemorrhage
|
100.0%
1/1 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Eye disorders
Photopsia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Eye disorders
Presbyopia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Eye disorders
Vision blurred
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Coeliac artery stenosis
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
100.0%
1/1 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
50.0%
3/6 • Number of events 3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
42.9%
3/7 • Number of events 4 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
13.3%
2/15 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
42.9%
3/7 • Number of events 3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
66.7%
2/3 • Number of events 4 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
50.0%
3/6 • Number of events 4 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
86.7%
13/15 • Number of events 23 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
83.3%
5/6 • Number of events 15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
20.0%
3/15 • Number of events 3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
83.3%
5/6 • Number of events 10 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
100.0%
3/3 • Number of events 10 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
71.4%
5/7 • Number of events 11 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
100.0%
3/3 • Number of events 10 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
83.3%
5/6 • Number of events 15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
80.0%
12/15 • Number of events 21 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
83.3%
5/6 • Number of events 11 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Tongue coated
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Tongue dry
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 4 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
57.1%
4/7 • Number of events 10 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
66.7%
4/6 • Number of events 7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
46.7%
7/15 • Number of events 11 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
50.0%
3/6 • Number of events 3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Facial pain
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
66.7%
4/6 • Number of events 7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
100.0%
3/3 • Number of events 6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
85.7%
6/7 • Number of events 7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
66.7%
2/3 • Number of events 5 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
66.7%
4/6 • Number of events 10 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
80.0%
12/15 • Number of events 17 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
100.0%
6/6 • Number of events 14 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Generalised oedema
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Malaise
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
13.3%
2/15 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Peripheral swelling
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
13.3%
2/15 • Number of events 4 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Candida infection
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Lung infection
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Blood glucose increased
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Coagulation time prolonged
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
20.0%
3/15 • Number of events 3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 4 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 5 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
13.3%
2/15 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
50.0%
3/6 • Number of events 5 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
71.4%
5/7 • Number of events 6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
50.0%
3/6 • Number of events 6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
73.3%
11/15 • Number of events 17 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
50.0%
3/6 • Number of events 6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
26.7%
4/15 • Number of events 7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
13.3%
2/15 • Number of events 4 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
5/15 • Number of events 5 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
66.7%
2/3 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
20.0%
3/15 • Number of events 3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
13.3%
2/15 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Allodynia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 4 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
13.3%
2/15 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
66.7%
2/3 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
20.0%
3/15 • Number of events 3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Tremor
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
13.3%
2/15 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
100.0%
1/1 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
13.3%
2/15 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
26.7%
4/15 • Number of events 5 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
100.0%
1/1 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hot flush
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/15 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
20.0%
3/15 • Number of events 3 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to approximately 10 months (Up to 30 days after last dose of study drug)
The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
|
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 investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study.
- Publication restrictions are in place
Restriction type: OTHER