Trial Outcomes & Findings for Once-Daily Oral Avatrombopag Tablets Used in Subjects With Chronic Liver Diseases and Thrombocytopenia Prior to Elective Surgical or Diagnostic Procedures (NCT NCT00914927)
NCT ID: NCT00914927
Last Updated: 2018-01-23
Results Overview
Platelet counts (PC) were determined from blood draws. A responder is defined as a participant having an increase of at least 20,000/mm\^3 PC from Baseline and a PC greater than 50,000/mm\^3 at least once during Day 4 through Day 8. Missing PC assessments at any given time point was considered to be a non-response at that point and were not estimated. For PC measurements taken after the last dose day (end of treatment (EOT)), the postdose windows applied. If there was more than one PC within the same analysis visit window, the following selection rules were applied sequentially to determine which PC was used for that time point: 1) the PC that was closer to the target date was used, 2) if PC were equal-distance in days from the target day, the later one based on measurement date and time was used, and 3) if there was more than one PC on the same day, if it was a baseline record, the largest one was used; if it was a postbaseline record, the smallest one was used.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
130 participants
Primary outcome timeframe
Day 8 (Visit 5, EOT)
Results posted on
2018-01-23
Participant Flow
Participant milestones
| Measure |
Cohort A: 20 mg Avatrombopag, 1G Formulation
Participants received a 100 mg loading dose of the first generation (1G) formulation avatrombopag on Day 1, followed by 20 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: 40 mg Avatrombopag, 1G Formulation
Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: 80 mg Avatrombopag, 1G Formulation
Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: Placebo, 1G Formulation
Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
|
Cohort B: 0 mg Avatrombopag, 2G Formulation
Participants received an 80 mg loading dose of the second generation (2G) formulation avatrombopag on Day 1, followed by 10 mg 2G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort B: 20 mg Avatrombopag, 2G Formulation
Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7.
|
Cohort B: Placebo, 2G Formulation
Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
16
|
17
|
16
|
21
|
21
|
21
|
|
Overall Study
COMPLETED
|
16
|
14
|
17
|
14
|
19
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
0
|
2
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort A: 20 mg Avatrombopag, 1G Formulation
Participants received a 100 mg loading dose of the first generation (1G) formulation avatrombopag on Day 1, followed by 20 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: 40 mg Avatrombopag, 1G Formulation
Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: 80 mg Avatrombopag, 1G Formulation
Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: Placebo, 1G Formulation
Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
|
Cohort B: 0 mg Avatrombopag, 2G Formulation
Participants received an 80 mg loading dose of the second generation (2G) formulation avatrombopag on Day 1, followed by 10 mg 2G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort B: 20 mg Avatrombopag, 2G Formulation
Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7.
|
Cohort B: Placebo, 2G Formulation
Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Administrative/Other
|
2
|
1
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Once-Daily Oral Avatrombopag Tablets Used in Subjects With Chronic Liver Diseases and Thrombocytopenia Prior to Elective Surgical or Diagnostic Procedures
Baseline characteristics by cohort
| Measure |
Cohort A: 20 mg Avatrombopag, 1G Formulation
n=18 Participants
Participants received a 100 mg loading dose of the first generation (1G) formulation avatrombopag on Day 1, followed by 20 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: 40 mg Avatrombopag, 1G Formulation
n=16 Participants
Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: 80 mg Avatrombopag, 1G Formulation
n=17 Participants
Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: Placebo, 1G Formulation
n=16 Participants
Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
|
Cohort B: 10 mg Avatrombopag, 2G Formulation
n=21 Participants
Participants received an 80 mg loading dose of the second generation (2G) formulation avatrombopag on Day 1, followed by 10 mg 2G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort B: 20 mg Avatrombopag, 2G Formulation
n=21 Participants
Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7.
|
Cohort B: Placebo, 2G Formulation
n=21 Participants
Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.3 Years
STANDARD_DEVIATION 7.16 • n=93 Participants
|
52.8 Years
STANDARD_DEVIATION 7.78 • n=4 Participants
|
55.2 Years
STANDARD_DEVIATION 5.96 • n=27 Participants
|
54.2 Years
STANDARD_DEVIATION 6.87 • n=483 Participants
|
53.9 Years
STANDARD_DEVIATION 5.48 • n=36 Participants
|
56.8 Years
STANDARD_DEVIATION 6.46 • n=10 Participants
|
55.6 Years
STANDARD_DEVIATION 6.52 • n=115 Participants
|
54.8 Years
STANDARD_DEVIATION 6.56 • n=40 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
7 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
42 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
11 Participants
n=36 Participants
|
14 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
88 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Day 8 (Visit 5, EOT)Population: Intent-to-treat (ITT) population included all participants who were randomized into the study, received study medication, and had a posttreatment assessment. The ITT population was analyzed as randomized.
Platelet counts (PC) were determined from blood draws. A responder is defined as a participant having an increase of at least 20,000/mm\^3 PC from Baseline and a PC greater than 50,000/mm\^3 at least once during Day 4 through Day 8. Missing PC assessments at any given time point was considered to be a non-response at that point and were not estimated. For PC measurements taken after the last dose day (end of treatment (EOT)), the postdose windows applied. If there was more than one PC within the same analysis visit window, the following selection rules were applied sequentially to determine which PC was used for that time point: 1) the PC that was closer to the target date was used, 2) if PC were equal-distance in days from the target day, the later one based on measurement date and time was used, and 3) if there was more than one PC on the same day, if it was a baseline record, the largest one was used; if it was a postbaseline record, the smallest one was used.
Outcome measures
| Measure |
Cohort A: 20 mg Avatrombopag, 1G Formulation
n=18 Participants
Participants received a 100 mg loading dose of the first generation (1G) formulation avatrombopag on Day 1, followed by 20 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: 40 mg Avatrombopag , 1G Formulation
n=16 Participants
Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: 80 mg Avatrombopag, 1G Formulation
n=17 Participants
Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: Placebo, 1G Formulation
n=16 Participants
Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
|
Cohort B:10 mg Avatrombopag, 2G Formulation
n=21 Participants
Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
|
Cohort B: 20 mg Avatrombopag, 2G Formulation
n=21 Participants
Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7.
|
Cohort B: Placebo, 2G Formulation
n=21 Participants
Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Response
Yes response
|
38.9 Percentage of participants
|
31.3 Percentage of participants
|
76.5 Percentage of participants
|
6.3 Percentage of participants
|
42.9 Percentage of participants
|
52.4 Percentage of participants
|
9.5 Percentage of participants
|
|
Percentage of Participants Experiencing Response
No response
|
61.1 Percentage of participants
|
68.8 Percentage of participants
|
23.5 Percentage of participants
|
93.8 Percentage of participants
|
57.1 Percentage of participants
|
47.6 Percentage of participants
|
90.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 8 (Visit 5, EOT)Population: Intent-to-treat population included all participants who were randomized into the study, received study medication, and had a posttreatment assessment. The ITT population was analyzed as randomized.
Platelet counts were determined from blood draws. Missing PC assessments at any given time point was considered to be a non-response at that point and were not estimated. For PC measurements taken after the last dose day (EOT), the postdose windows applied. If there was more than one PC within the same analysis visit window, the following selection rules were applied sequentially to determine which PC was used for that time point: 1) the PC that was closer to the target date was used, 2) if PC were equal-distance in days from the target day, the later one based on measurement date and time was used, and 3) if there was more than one PC on the same day, if it was a baseline record, the largest one was used; if it was a postbaseline record, the smallest one was used.
Outcome measures
| Measure |
Cohort A: 20 mg Avatrombopag, 1G Formulation
n=18 Participants
Participants received a 100 mg loading dose of the first generation (1G) formulation avatrombopag on Day 1, followed by 20 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: 40 mg Avatrombopag , 1G Formulation
n=16 Participants
Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: 80 mg Avatrombopag, 1G Formulation
n=17 Participants
Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: Placebo, 1G Formulation
n=16 Participants
Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
|
Cohort B:10 mg Avatrombopag, 2G Formulation
n=21 Participants
Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
|
Cohort B: 20 mg Avatrombopag, 2G Formulation
n=21 Participants
Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7.
|
Cohort B: Placebo, 2G Formulation
n=21 Participants
Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
|
|---|---|---|---|---|---|---|---|
|
Change in Platelet Count on Day 8 (Visit 5 and/or End of Treatment) From Baseline
|
16.2 K/mm^3
Standard Deviation 10.32
|
15.9 K/mm^3
Standard Deviation 13.45
|
32.2 K/mm^3
Standard Deviation 18.59
|
3.1 K/mm^3
Standard Deviation 17.97
|
18.9 K/mm^3
Standard Deviation 10.07
|
24.9 K/mm^3
Standard Deviation 17.91
|
3.9 K/mm^3
Standard Deviation 12.49
|
SECONDARY outcome
Timeframe: Day 4 (Visit 3), Day 6 ( Visit 4), Day 8 (Visit 5, EOT), 3 Day Post Last Dose (Visit 6), and 7 Day Post Last Dose (Visit 7)Population: Intent-to-treat population included all participants who were randomized into the study, received study medication, and had a posttreatment assessment. The ITT population was analyzed as randomized.
Platelet counts were determined from blood draws. Missing PC assessments at any given time point was considered to be a non-response at that point and were not estimated. For PC measurements taken after the last dose day (EOT), the postdose windows applied. If there was more than one PC within the same analysis visit window, the following selection rules were applied sequentially to determine which PC was used for that time point: 1) the PC that was closer to the target date was used, 2) if PC were equal-distance in days from the target day, the later one based on measurement date and time was used, and 3) if there was more than one PC on the same day, if it was a baseline record, the largest one was used; if it was a postbaseline record, the smallest one was used.
Outcome measures
| Measure |
Cohort A: 20 mg Avatrombopag, 1G Formulation
n=18 Participants
Participants received a 100 mg loading dose of the first generation (1G) formulation avatrombopag on Day 1, followed by 20 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: 40 mg Avatrombopag , 1G Formulation
n=16 Participants
Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: 80 mg Avatrombopag, 1G Formulation
n=17 Participants
Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: Placebo, 1G Formulation
n=16 Participants
Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
|
Cohort B:10 mg Avatrombopag, 2G Formulation
n=21 Participants
Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
|
Cohort B: 20 mg Avatrombopag, 2G Formulation
n=21 Participants
Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7.
|
Cohort B: Placebo, 2G Formulation
n=21 Participants
Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Dose-response by Visit
Yes response (Day 4, Visit 3)
|
0 Percentage of participants
|
0 Percentage of participants
|
5.9 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
4.8 Percentage of participants
|
4.8 Percentage of participants
|
|
Percentage of Participants Experiencing Dose-response by Visit
No response (Day 4, Visit 3)
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
94.1 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
95.2 Percentage of participants
|
95.2 Percentage of participants
|
|
Percentage of Participants Experiencing Dose-response by Visit
Yes response (Day 6, Visit 4)
|
11.1 Percentage of participants
|
12.5 Percentage of participants
|
29.4 Percentage of participants
|
0 Percentage of participants
|
14.3 Percentage of participants
|
33.3 Percentage of participants
|
9.5 Percentage of participants
|
|
Percentage of Participants Experiencing Dose-response by Visit
No response (Day 6, Visit 4)
|
88.9 Percentage of participants
|
87.5 Percentage of participants
|
70.6 Percentage of participants
|
100.0 Percentage of participants
|
85.7 Percentage of participants
|
66.7 Percentage of participants
|
90.5 Percentage of participants
|
|
Percentage of Participants Experiencing Dose-response by Visit
Yes response (Day 8, Visit 5)
|
38.9 Percentage of participants
|
31.3 Percentage of participants
|
76.5 Percentage of participants
|
6.3 Percentage of participants
|
42.9 Percentage of participants
|
52.4 Percentage of participants
|
9.5 Percentage of participants
|
|
Percentage of Participants Experiencing Dose-response by Visit
No response (Day 8, Visit 5)
|
61.1 Percentage of participants
|
68.8 Percentage of participants
|
23.5 Percentage of participants
|
93.8 Percentage of participants
|
57.1 Percentage of participants
|
47.6 Percentage of participants
|
90.5 Percentage of participants
|
|
Percentage of Participants Experiencing Dose-response by Visit
Yes response (3 Day post last dose, Visit 6)
|
55.6 Percentage of participants
|
56.3 Percentage of participants
|
82.4 Percentage of participants
|
12.5 Percentage of participants
|
66.7 Percentage of participants
|
61.9 Percentage of participants
|
9.5 Percentage of participants
|
|
Percentage of Participants Experiencing Dose-response by Visit
No response (3 Day post last dose, Visit 6)
|
44.4 Percentage of participants
|
43.8 Percentage of participants
|
17.6 Percentage of participants
|
87.5 Percentage of participants
|
33.3 Percentage of participants
|
38.1 Percentage of participants
|
90.5 Percentage of participants
|
|
Percentage of Participants Experiencing Dose-response by Visit
Yes response (7 Day post last dose, Visit 7)
|
61.1 Percentage of participants
|
62.5 Percentage of participants
|
88.2 Percentage of participants
|
12.5 Percentage of participants
|
71.4 Percentage of participants
|
61.9 Percentage of participants
|
9.5 Percentage of participants
|
|
Percentage of Participants Experiencing Dose-response by Visit
No response (7 Day post last dose, Visit 7)
|
38.9 Percentage of participants
|
37.5 Percentage of participants
|
11.8 Percentage of participants
|
87.5 Percentage of participants
|
28.6 Percentage of participants
|
38.1 Percentage of participants
|
90.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 4 (Visit 3)Population: Intent-to-treat population included all participants who were randomized into the study, received study medication, and had a posttreatment assessment. The ITT population was analyzed as randomized.
Platelet counts were determined from blood draws. Missing PC assessments at any given time point was considered to be a non-response at that point and were not estimated. For PC measurements taken after the last dose day (EOT), the postdose windows applied. If there was more than one PC within the same analysis visit window, the following selection rules were applied sequentially to determine which PC was used for that time point: 1) the PC that was closer to the target date was used, 2) if PC were equal-distance in days from the target day, the later one based on measurement date and time was used, and 3) if there was more than one PC on the same day, if it was a baseline record, the largest one was used; if it was a postbaseline record, the smallest one was used.
Outcome measures
| Measure |
Cohort A: 20 mg Avatrombopag, 1G Formulation
n=18 Participants
Participants received a 100 mg loading dose of the first generation (1G) formulation avatrombopag on Day 1, followed by 20 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: 40 mg Avatrombopag , 1G Formulation
n=16 Participants
Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: 80 mg Avatrombopag, 1G Formulation
n=17 Participants
Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: Placebo, 1G Formulation
n=16 Participants
Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
|
Cohort B:10 mg Avatrombopag, 2G Formulation
n=21 Participants
Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
|
Cohort B: 20 mg Avatrombopag, 2G Formulation
n=21 Participants
Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7.
|
Cohort B: Placebo, 2G Formulation
n=21 Participants
Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved a Platelet Count Greater Than 75,000/mm^3 on Day 4
Yes response
|
5.6 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Achieved a Platelet Count Greater Than 75,000/mm^3 on Day 4
No response
|
94.4 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 4 (Visit 3) and Day 8 (Visit 5, EOT)Population: Intent-to-treat population included all participants who were randomized into the study, received study medication, and had a posttreatment assessment. The ITT population was analyzed as randomized.
Platelet counts were determined from blood draws. Missing PC assessments at any given time point was considered to be a non-response at that point and were not estimated. For PC measurements taken after the last dose day (EOT), the postdose windows applied. If there was more than one PC within the same analysis visit window, the following selection rules were applied sequentially to determine which PC was used for that time point: 1) the PC that was closer to the target date was used, 2) if PC were equal-distance in days from the target day, the later one based on measurement date and time was used, and 3) if there was more than one PC on the same day, if it was a baseline record, the largest one was used; if it was a postbaseline record, the smallest one was used.
Outcome measures
| Measure |
Cohort A: 20 mg Avatrombopag, 1G Formulation
n=18 Participants
Participants received a 100 mg loading dose of the first generation (1G) formulation avatrombopag on Day 1, followed by 20 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: 40 mg Avatrombopag , 1G Formulation
n=16 Participants
Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: 80 mg Avatrombopag, 1G Formulation
n=17 Participants
Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: Placebo, 1G Formulation
n=16 Participants
Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
|
Cohort B:10 mg Avatrombopag, 2G Formulation
n=21 Participants
Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
|
Cohort B: 20 mg Avatrombopag, 2G Formulation
n=21 Participants
Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7.
|
Cohort B: Placebo, 2G Formulation
n=21 Participants
Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved a Platelet Count Greater Than 100,000/mm^3 on Days 4 and 8
Yes response (Day 4, Visit 3)
|
5.6 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Achieved a Platelet Count Greater Than 100,000/mm^3 on Days 4 and 8
No response (Day 4, Visit 3)
|
94.4 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants Who Achieved a Platelet Count Greater Than 100,000/mm^3 on Days 4 and 8
Yes response (Day 8, Visit 5)
|
5.6 Percentage of participants
|
0 Percentage of participants
|
11.8 Percentage of participants
|
0 Percentage of participants
|
4.8 Percentage of participants
|
9.5 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Achieved a Platelet Count Greater Than 100,000/mm^3 on Days 4 and 8
No response (Day 8, Visit 5)
|
94.4 Percentage of participants
|
100.0 Percentage of participants
|
88.2 Percentage of participants
|
100.0 Percentage of participants
|
95.2 Percentage of participants
|
90.5 Percentage of participants
|
100.0 Percentage of participants
|
Adverse Events
Cohort A: 20 mg Avatrombopag, 1G Formulation
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
Cohort A: 40 mg Avatrombopag, 1G Formulation
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Cohort A: 80 mg Avatrombopag, 1G Formulation
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Cohort A: Placebo, 1G Formulation
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Cohort B: 10 mg Avatrombopag, 2G Formulation
Serious events: 5 serious events
Other events: 17 other events
Deaths: 1 deaths
Cohort B: 20 mg Avatrombopag, 2G Formulation
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Cohort B: Placebo, 2G Formulation
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A: 20 mg Avatrombopag, 1G Formulation
n=18 participants at risk
Participants received a 100 mg loading dose of the first generation (1G) formulation avatrombopag on Day 1, followed by 20 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: 40 mg Avatrombopag, 1G Formulation
n=16 participants at risk
Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: 80 mg Avatrombopag, 1G Formulation
n=17 participants at risk
Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: Placebo, 1G Formulation
n=16 participants at risk
Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
|
Cohort B: 10 mg Avatrombopag, 2G Formulation
n=21 participants at risk
Participants received an 80 mg loading dose of the second generation (2G) formulation avatrombopag on Day 1, followed by 10 mg 2G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort B: 20 mg Avatrombopag, 2G Formulation
n=21 participants at risk
Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7.
|
Cohort B: Placebo, 2G Formulation
n=21 participants at risk
Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
|
|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Infections and infestations
Pneumonia
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Heamorrhoidal haemorrhage
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Infections and infestations
Staphylcoccal abscess
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
Other adverse events
| Measure |
Cohort A: 20 mg Avatrombopag, 1G Formulation
n=18 participants at risk
Participants received a 100 mg loading dose of the first generation (1G) formulation avatrombopag on Day 1, followed by 20 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: 40 mg Avatrombopag, 1G Formulation
n=16 participants at risk
Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: 80 mg Avatrombopag, 1G Formulation
n=17 participants at risk
Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort A: Placebo, 1G Formulation
n=16 participants at risk
Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
|
Cohort B: 10 mg Avatrombopag, 2G Formulation
n=21 participants at risk
Participants received an 80 mg loading dose of the second generation (2G) formulation avatrombopag on Day 1, followed by 10 mg 2G formulation avatrombopag once daily on Days 2 to 7.
|
Cohort B: 20 mg Avatrombopag, 2G Formulation
n=21 participants at risk
Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7.
|
Cohort B: Placebo, 2G Formulation
n=21 participants at risk
Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Helicobacter infection
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Investigations
Weight increased
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
12.5%
2/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
12.5%
2/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
9.5%
2/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Ear and labyrinth disorders
Ear pain
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Eye disorders
Visual impairment
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
9.5%
2/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
14.3%
3/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
22.2%
4/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Ascites
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
14.3%
3/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Colonic polyp
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
2/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
2/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
14.3%
3/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
9.5%
2/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Dry mouth
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Erosive duodenitis
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Gastric polyps
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Gastric verices
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
9.5%
2/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
11.8%
2/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Intestinal polyp
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
12.5%
2/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
11.8%
2/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
12.5%
2/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
23.8%
5/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
9.5%
2/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
14.3%
3/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Oesophageal mass
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Polyp colorectal
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Portal hypertensive gastropathy
|
22.2%
4/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
12.5%
2/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
14.3%
3/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
9.5%
2/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Varices oesophageal
|
11.1%
2/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
12.5%
2/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
9.5%
2/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
12.5%
2/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
17.6%
3/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
General disorders
Chills
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
General disorders
Fatigue
|
22.2%
4/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
9.5%
2/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
9.5%
2/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
19.0%
4/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
General disorders
Hyperthermia
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
General disorders
Irritability
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Infections and infestations
Fungal skin infection
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
General disorders
Malaise
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
General disorders
Oedema peripheral
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
11.8%
2/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
9.5%
2/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
General disorders
Pyrexia
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
11.8%
2/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
12.5%
2/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
14.3%
3/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
9.5%
2/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Infections and infestations
Localised infection
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
11.8%
2/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Infections and infestations
Oral herpes
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Infections and infestations
Pneumonia
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Infections and infestations
Sinusitus
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Infections and infestations
Staphylococcal skin infection
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Injury, poisoning and procedural complications
Arthropid bite
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Injury, poisoning and procedural complications
Iris injury
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Injury, poisoning and procedural complications
Laceration
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
12.5%
2/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
11.8%
2/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
9.5%
2/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Injury, poisoning and procedural complications
Scratch
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Investigations
Blood creatinine increased
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Investigations
Blood glucose increased
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Investigations
Blood urine present
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Investigations
Electrocardiogram T wave peaked
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Investigations
Glucose urine present
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Investigations
Heart rate increased
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Investigations
Urine output decreased
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
12.5%
2/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
11.1%
2/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
11.1%
2/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
11.8%
2/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
9.5%
2/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
2/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
11.1%
2/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Nervous system disorders
Dizziness
|
11.1%
2/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
14.3%
3/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Nervous system disorders
Dysgeusia
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Nervous system disorders
Headache
|
11.1%
2/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
12.5%
2/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
12.5%
2/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
14.3%
3/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
14.3%
3/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Nervous system disorders
Hepatic encephalopathy
|
11.1%
2/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Nervous system disorders
Sinus headache
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Nervous system disorders
Unresponsive to stimuli
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Psychiatric disorders
Depression
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Psychiatric disorders
Insomnia
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Psychiatric disorders
Listless
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Psychiatric disorders
Mental status change
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Renal and urinary disorders
Renal failure acute
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Reproductive system and breast disorders
Pelvic pain
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Reproductive system and breast disorders
Scrotal swelling
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.1%
2/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
2/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Vascular disorders
Hypertension
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
5.9%
1/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Vascular disorders
Hypotension
|
5.6%
1/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
6.2%
1/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
4.8%
1/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
9.5%
2/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Cardiac disorders
Pulmonary valve incompetence
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
9.5%
2/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
9.5%
2/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Eye disorders
Ocular icterus
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
9.5%
2/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
9.5%
2/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Faeces discolored
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
9.5%
2/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
9.5%
2/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
9.5%
2/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
14.3%
3/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
9.5%
2/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
9.5%
2/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
9.5%
2/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
9.5%
2/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
9.5%
2/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.00%
0/18 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/17 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/16 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
9.5%
2/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
0.00%
0/21 • Approximately 44 days.
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported. The safety population included all randomized participants who received at least one dose of study drug and had a postbaseline safety assessment. The safety population was analyzed as treated.
|
Additional Information
Eisai Medical Services
Eisai Inc.
Phone: 1-888-422-4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER