Trial Outcomes & Findings for A Study of LY3509754 in Healthy Non-Japanese and Japanese Participants (NCT NCT04586920)
NCT ID: NCT04586920
Last Updated: 2025-01-03
Results Overview
An SAE is any adverse event (AE) from the study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e., immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported here. A summary of SAEs and other non-serious AEs, regardless of causality, will be reported in the Reported Adverse Events module.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
104 participants
Primary outcome timeframe
Baseline up to Day 26
Results posted on
2025-01-03
Participant Flow
Participant milestones
| Measure |
Part A - 300 mg LY3509754 (Fasted and Fed)
Participants received a single oral dose of 300 mg LY3509754 under fasting condition. There was a washout period of at least 5 days. Participants received a single oral dose of 300 mg LY3509754 under fed condition.
|
Part A - Placebo (Fasted)
Participants received single oral dose of placebo under fasting condition.
|
Part A - Placebo (Fed)
Participants received single oral dose of placebo under fed condition.
|
Part A - 10 Milligram (mg) LY3509754 (Fasted)
Participants received a single oral dose of 10 mg LY3509754 under fasting condition.
|
Part A - 30 mg LY3509754 (Fasted)
Participants received a single oral dose of 30 mg LY3509754 under fasting condition.
|
Part A - 100 mg LY3509754 (Fasted)
Participants received a single oral dose of 100 mg LY3509754 under fasting condition.
|
Part A - 1000 mg LY3509754 (Fasted)
Participants received a single oral dose of 1000 mg LY3509754 under fasting condition.
|
Part A - 2000 mg LY3509754 (Fasted)
Participants received a single oral dose of 2000 mg LY3509754 under fasting condition.
|
Part B - Placebo + 200 mg Itraconazole (Day 10)
Participants received a single oral dose of placebo on Day 1 followed by daily doses of 200 mg itraconazole as oral solution for 10 days twice daily (BID) on Day 4 and once daily (QD) from Days 5 through 13. Participants received a single oral dose of placebo on Day 10.
|
Part B - 10 mg LY3509754 + 200 mg Itraconazole (Day 10)
Participants received a single oral dose of 10 mg LY3509754 on Day 1 followed by daily doses of 200 mg itraconazole as oral solution for 10 days BID on Day 4 and QD from Days 5 through 13. Participants received a single oral dose of placebo on Day 10.
|
Part C - QD [Cohorts 1 and 3]
Participants received oral doses of placebo QD for 14 Days.
|
Part C - 100 mg LY3509754 QD [Cohort 1]
Participants received oral doses of 100 mg LY3509754 QD for 14 Days.
|
Part C - Placebo QD + 1.2 mg Midazolam [Cohort 2]
Participants received a single dose of 1.2 mg midazolam given as oral solution on Day -2 followed by oral doses of placebo QD from Day 1 to 15. Participants then received a single dose of 1.2 mg midazolam given as oral solution on Day 15.
|
Part C - 300 mg LY3509754 QD + 1.2 mg Midazolam [Cohort 2]
Participants received a single dose of 1.2 mg midazolam given as oral solution on Day -2 followed by oral doses of 300 mg LY3509754 QD from Day 1 to 15. Participants then received a single dose of 1.2 mg midazolam given as oral solution on Day 15.
|
Part C - 1000 mg LY3509754 QD [Cohort 3]
Participants received oral doses of 1000 mg LY3509754 QD for 14 Days.
|
Part D (Japanese) - Placebo QD
Participants received oral doses of placebo QD for 14 Days.
|
Part D (Japanese) - 400 mg LY3509754 QD
Participants received oral doses of 400 mg LY3509754 QD for 14 Days.
|
Part D (Japanese) - 1000 mg LY3509754 QD
Participants received oral doses of 1000 mg LY3509754 QD for 14 Days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
2
|
6
|
6
|
6
|
6
|
6
|
3
|
8
|
4
|
6
|
2
|
8
|
6
|
4
|
6
|
6
|
|
Overall Study
Received At Least One Dose of Study Drug
|
9
|
10
|
2
|
6
|
6
|
6
|
6
|
6
|
3
|
8
|
4
|
6
|
2
|
8
|
6
|
4
|
6
|
6
|
|
Overall Study
COMPLETED
|
9
|
10
|
2
|
6
|
6
|
6
|
5
|
4
|
3
|
6
|
4
|
5
|
2
|
7
|
6
|
4
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
2
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part A - 300 mg LY3509754 (Fasted and Fed)
Participants received a single oral dose of 300 mg LY3509754 under fasting condition. There was a washout period of at least 5 days. Participants received a single oral dose of 300 mg LY3509754 under fed condition.
|
Part A - Placebo (Fasted)
Participants received single oral dose of placebo under fasting condition.
|
Part A - Placebo (Fed)
Participants received single oral dose of placebo under fed condition.
|
Part A - 10 Milligram (mg) LY3509754 (Fasted)
Participants received a single oral dose of 10 mg LY3509754 under fasting condition.
|
Part A - 30 mg LY3509754 (Fasted)
Participants received a single oral dose of 30 mg LY3509754 under fasting condition.
|
Part A - 100 mg LY3509754 (Fasted)
Participants received a single oral dose of 100 mg LY3509754 under fasting condition.
|
Part A - 1000 mg LY3509754 (Fasted)
Participants received a single oral dose of 1000 mg LY3509754 under fasting condition.
|
Part A - 2000 mg LY3509754 (Fasted)
Participants received a single oral dose of 2000 mg LY3509754 under fasting condition.
|
Part B - Placebo + 200 mg Itraconazole (Day 10)
Participants received a single oral dose of placebo on Day 1 followed by daily doses of 200 mg itraconazole as oral solution for 10 days twice daily (BID) on Day 4 and once daily (QD) from Days 5 through 13. Participants received a single oral dose of placebo on Day 10.
|
Part B - 10 mg LY3509754 + 200 mg Itraconazole (Day 10)
Participants received a single oral dose of 10 mg LY3509754 on Day 1 followed by daily doses of 200 mg itraconazole as oral solution for 10 days BID on Day 4 and QD from Days 5 through 13. Participants received a single oral dose of placebo on Day 10.
|
Part C - QD [Cohorts 1 and 3]
Participants received oral doses of placebo QD for 14 Days.
|
Part C - 100 mg LY3509754 QD [Cohort 1]
Participants received oral doses of 100 mg LY3509754 QD for 14 Days.
|
Part C - Placebo QD + 1.2 mg Midazolam [Cohort 2]
Participants received a single dose of 1.2 mg midazolam given as oral solution on Day -2 followed by oral doses of placebo QD from Day 1 to 15. Participants then received a single dose of 1.2 mg midazolam given as oral solution on Day 15.
|
Part C - 300 mg LY3509754 QD + 1.2 mg Midazolam [Cohort 2]
Participants received a single dose of 1.2 mg midazolam given as oral solution on Day -2 followed by oral doses of 300 mg LY3509754 QD from Day 1 to 15. Participants then received a single dose of 1.2 mg midazolam given as oral solution on Day 15.
|
Part C - 1000 mg LY3509754 QD [Cohort 3]
Participants received oral doses of 1000 mg LY3509754 QD for 14 Days.
|
Part D (Japanese) - Placebo QD
Participants received oral doses of placebo QD for 14 Days.
|
Part D (Japanese) - 400 mg LY3509754 QD
Participants received oral doses of 400 mg LY3509754 QD for 14 Days.
|
Part D (Japanese) - 1000 mg LY3509754 QD
Participants received oral doses of 1000 mg LY3509754 QD for 14 Days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of LY3509754 in Healthy Non-Japanese and Japanese Participants
Baseline characteristics by cohort
| Measure |
Part A - Placebo (Fasted)
n=10 Participants
Participants received single oral dose of placebo under fasting condition.
|
Part A - Placebo (Fed)
n=2 Participants
Participants received single oral dose of placebo under fed condition.
|
Part A - 10 mg LY3509754 (Fasted)
n=6 Participants
Participants received a single oral dose of 10 mg LY3509754 under fasting condition.
|
Part A - 30 mg LY3509754 (Fasted)
n=6 Participants
Participants received a single oral dose of 30 mg LY3509754 under fasting condition.
|
Part A - 100 mg LY3509754 (Fasted)
n=6 Participants
Participants received a single oral dose of 100 mg LY3509754 under fasting condition.
|
Part A - 300 mg LY3509754 (Fasted and Fed)
n=9 Participants
Participants received a single oral dose of 300 mg LY3509754 under fasting condition. There was a washout period of at least 5 days. Participants received a single oral dose of 300 mg LY3509754 under fed condition.
|
Part A - 1000 mg LY3509754 (Fasted)
n=6 Participants
Participants received a single oral dose of 1000 mg LY3509754 under fasting condition.
|
Part A - 2000 mg LY3509754 (Fasted)
n=6 Participants
Participants received a single oral dose of 2000 mg LY3509754 under fasting condition.
|
Part B - Placebo + 200 mg Itraconazole (Day 10)
n=3 Participants
Participants received a single oral dose of placebo on Day 1 followed by daily doses of 200 mg itraconazole as oral solution for 10 days BID on Day 4 and QD from Days 5 through 13. Participants received a single oral dose of placebo on Day 10.
|
Part B - 10 mg LY3509754 + 200 mg Itraconazole (Day 10)
n=8 Participants
Participants received a single oral dose of 10 mg LY3509754 on Day 1 followed by daily doses of 200 mg itraconazole as oral solution for 10 days BID on Day 4 and QD from Days 5 through 13. Participants received a single oral dose of placebo on Day 10.
|
Part C - Placebo QD [Cohorts 1 and 3]
n=4 Participants
Participants received oral doses of placebo QD for 14 Days.
|
Part C - 100 mg LY3509754 QD [Cohort 1]
n=6 Participants
Participants received oral doses of 100 mg LY3509754 QD for 14 Days.
|
Part C - Placebo QD + 1.2 mg Midazolam [Cohort 2]
n=2 Participants
Participants received a single dose of 1.2 mg midazolam given as oral solution on Day -2 followed by oral doses of placebo QD from Day 1 to 15. Participants then received a single dose of 1.2 mg midazolam given as oral solution on Day 15.
|
Part C - 300 mg LY3509754 QD + 1.2 mg Midazolam [Cohort 2]
n=8 Participants
Participants received a single dose of 1.2 mg midazolam given as oral solution on Day -2 followed by oral doses of 300 mg LY3509754 QD from Day 1 to 15. Participants then received a single dose of 1.2 mg midazolam given as oral solution on Day 15.
|
Part C - 1000 mg LY3509754 QD [Cohort 3]
n=6 Participants
Participants received oral doses of 1000 mg LY3509754 QD for 14 Days.
|
Part D (Japanese) - Placebo QD
n=4 Participants
Participants received oral doses of placebo QD for 14 Days.
|
Part D (Japanese) - 400 mg LY3509754 QD
n=6 Participants
Participants received oral doses of 400 mg LY3509754 QD for 14 Days.
|
Part D (Japanese) - 1000 mg LY3509754 QD
n=6 Participants
Participants received oral doses of 1000 mg LY3509754 QD for 14 Days.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
49.4 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
43.5 years
STANDARD_DEVIATION 3.5 • n=7 Participants
|
43.8 years
STANDARD_DEVIATION 16.1 • n=5 Participants
|
43.8 years
STANDARD_DEVIATION 11.0 • n=4 Participants
|
52.0 years
STANDARD_DEVIATION 10.4 • n=21 Participants
|
52.9 years
STANDARD_DEVIATION 13.3 • n=8 Participants
|
56.8 years
STANDARD_DEVIATION 4.6 • n=8 Participants
|
42.0 years
STANDARD_DEVIATION 14.3 • n=24 Participants
|
33.3 years
STANDARD_DEVIATION 6.8 • n=42 Participants
|
42.6 years
STANDARD_DEVIATION 9.4 • n=42 Participants
|
44.0 years
STANDARD_DEVIATION 8.5 • n=42 Participants
|
43.2 years
STANDARD_DEVIATION 15.3 • n=42 Participants
|
38.0 years
STANDARD_DEVIATION 2.8 • n=36 Participants
|
46.5 years
STANDARD_DEVIATION 16.1 • n=36 Participants
|
48.2 years
STANDARD_DEVIATION 12.2 • n=24 Participants
|
52.5 years
STANDARD_DEVIATION 11.9 • n=135 Participants
|
54.0 years
STANDARD_DEVIATION 7.5 • n=136 Participants
|
50.0 years
STANDARD_DEVIATION 9.1 • n=44 Participants
|
47.45 years
STANDARD_DEVIATION 12.13 • n=667 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
2 Participants
n=44 Participants
|
27 Participants
n=667 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
5 Participants
n=36 Participants
|
6 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
4 Participants
n=136 Participants
|
4 Participants
n=44 Participants
|
77 Participants
n=667 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
26 Participants
n=667 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
8 Participants
n=36 Participants
|
5 Participants
n=24 Participants
|
4 Participants
n=135 Participants
|
6 Participants
n=136 Participants
|
6 Participants
n=44 Participants
|
78 Participants
n=667 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=135 Participants
|
6 Participants
n=136 Participants
|
6 Participants
n=44 Participants
|
18 Participants
n=667 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
38 Participants
n=667 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
44 Participants
n=667 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
2 Participants
n=667 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
8 Participants
n=36 Participants
|
6 Participants
n=24 Participants
|
4 Participants
n=135 Participants
|
6 Participants
n=136 Participants
|
6 Participants
n=44 Participants
|
104 Participants
n=667 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 26Population: All participants who received at least one dose of study drug.
An SAE is any adverse event (AE) from the study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e., immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported here. A summary of SAEs and other non-serious AEs, regardless of causality, will be reported in the Reported Adverse Events module.
Outcome measures
| Measure |
Part A - Placebo (Fasted)
n=10 Participants
Participants received single oral dose of placebo under fasting condition.
|
Part A - Placebo (Fed)
n=2 Participants
Participants received single oral dose of placebo under fed condition.
|
Part A - 10 Milligram (mg) LY3509754 (Fasted)
n=6 Participants
Participants received a single oral dose of 10 mg LY3509754 under fasting condition.
|
Part A - 30 mg LY3509754 (Fasted)
n=6 Participants
Participants received a single oral dose of 30 mg LY3509754 under fasting condition.
|
Part A - 100 mg LY3509754 (Fasted)
n=6 Participants
Participants received a single oral dose of 100 mg LY3509754 under fasting condition.
|
Part A - 300 mg LY3509754 (Fasted)
n=9 Participants
Participants received a single oral dose of 300 mg LY3509754 under fasting condition.
|
Part A - 300 mg LY3509754 (Fed)
n=9 Participants
Participants received a single oral dose of 300 mg LY3509754 under fed condition.
|
Part A - 1000 mg LY3509754 (Fasted)
n=6 Participants
Participants received a single oral dose of 1000 mg LY3509754 under fasting condition.
|
Part A - 2000 mg LY3509754 (Fasted)
n=6 Participants
Participants received a single oral dose of 2000 mg LY3509754 under fasting condition.
|
Part B - Placebo Alone (Day 1)
n=3 Participants
Participants received a single oral dose of placebo on Day 1.
|
Part B - Placebo + 200 mg Itraconazole (Day 10)
n=3 Participants
Participants received a single oral dose of placebo and 200 mg itraconazole oral solution on Day 10.
|
Part B - 200 mg Itraconazole (Days 4 to 13)
n=11 Participants
Participants received 200 mg itraconazole as an oral solution BID on Day 4 and QD on Days 5 through 13.
|
Part B - 10 mg LY3509754 Alone (Day 1)
n=8 Participants
Participants received a single oral dose of 10 mg LY3509754 on Day 1.
|
Part B - 10 mg LY3509754 + 200 mg Itraconazole (Day 10)
n=8 Participants
Participants received a single oral dose of 10 mg LY3509754 and 200 mg itraconazole oral solution on Day 10.
|
Part C - Placebo QD [Cohorts 1 and 3]
n=4 Participants
Participants received oral doses of placebo QD for 14 Days.
|
Part C - 100 mg LY3509754 QD [Cohort 1]
n=6 Participants
Participants received oral doses of 100 mg LY3509754 QD for 14 Days.
|
Part C - 1.2 mg Midazolam (Day -2) [Cohort 2]
n=10 Participants
Participants received 1.2 mg midazolam as an oral solution on Day -2.
|
Part C - Placebo QD (Days 1 to 14) [Cohort 2]
n=2 Participants
Participants received oral doses of placebo QD for 14 Days upon receiving 1.2 mg midazolam on Day -2.
|
Part C - 300 mg LY3509754 QD (Days 1 to 14) [Cohort 2]
n=8 Participants
Participants received oral doses 300 mg of LY3509754 QD for 14 Days upon receiving 1.2 mg midazolam on Day -2.
|
Part C - Placebo QD + 1.2 mg Midazolam (Day 15) [Cohort 2]
n=2 Participants
Participants received a single oral dose of placebo QD along with 1.2 mg midazolam given as oral solution on Day 15.
|
Part C - 300 mg LY3509754 QD + 1.2 mg Midazolam (Day 15) [Cohort 2]
n=8 Participants
Participants received a single oral dose of 300 mg LY3509754 QD along with 1.2 mg midazolam given as oral solution on Day 15.
|
Part C - 1000 mg LY3509754 QD [Cohort 3]
n=6 Participants
Participants received oral doses of 1000 mg LY3509754 QD for 14 Days.
|
Part D (Japanese) - Placebo QD
n=4 Participants
Participants received oral doses of placebo QD for 14 Days.
|
Part D (Japanese) - 400 mg LY3509754 QD
n=6 Participants
Participants received oral doses of 400 mg LY3509754 QD for 14 Days.
|
Part D (Japanese) - 1000 mg LY3509754 QD
n=6 Participants
Participants received oral doses of 1000 mg LY3509754 QD for 14 Days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Part A: Pre-dose (P), 0.5,1,2,3,4,5,6,8,12,16,24,36,48,72,96 hours (h) post Day 1 dose. Part B: P,0.5,1,2,3,4,6,8,12,16,24,36,48,72,96 h post Day 1 dose; P,0.5,1,2,3,4,6,8,12,16,24,36,48,72,96,120,144,168 h Post Day 10 dose.Population: All participants who received at least one dose of LY3509754 or itraconazole and had evaluable PK data.
PK: Cmax of LY3509754 in Parts A and B.
Outcome measures
| Measure |
Part A - Placebo (Fasted)
n=6 Participants
Participants received single oral dose of placebo under fasting condition.
|
Part A - Placebo (Fed)
n=6 Participants
Participants received single oral dose of placebo under fed condition.
|
Part A - 10 Milligram (mg) LY3509754 (Fasted)
n=6 Participants
Participants received a single oral dose of 10 mg LY3509754 under fasting condition.
|
Part A - 30 mg LY3509754 (Fasted)
n=9 Participants
Participants received a single oral dose of 30 mg LY3509754 under fasting condition.
|
Part A - 100 mg LY3509754 (Fasted)
n=9 Participants
Participants received a single oral dose of 100 mg LY3509754 under fasting condition.
|
Part A - 300 mg LY3509754 (Fasted)
n=6 Participants
Participants received a single oral dose of 300 mg LY3509754 under fasting condition.
|
Part A - 300 mg LY3509754 (Fed)
n=6 Participants
Participants received a single oral dose of 300 mg LY3509754 under fed condition.
|
Part A - 1000 mg LY3509754 (Fasted)
n=8 Participants
Participants received a single oral dose of 1000 mg LY3509754 under fasting condition.
|
Part A - 2000 mg LY3509754 (Fasted)
n=8 Participants
Participants received a single oral dose of 2000 mg LY3509754 under fasting condition.
|
Part B - Placebo Alone (Day 1)
Participants received a single oral dose of placebo on Day 1.
|
Part B - Placebo + 200 mg Itraconazole (Day 10)
Participants received a single oral dose of placebo and 200 mg itraconazole oral solution on Day 10.
|
Part B - 200 mg Itraconazole (Days 4 to 13)
Participants received 200 mg itraconazole as an oral solution BID on Day 4 and QD on Days 5 through 13.
|
Part B - 10 mg LY3509754 Alone (Day 1)
Participants received a single oral dose of 10 mg LY3509754 on Day 1.
|
Part B - 10 mg LY3509754 + 200 mg Itraconazole (Day 10)
Participants received a single oral dose of 10 mg LY3509754 and 200 mg itraconazole oral solution on Day 10.
|
Part C - Placebo QD [Cohorts 1 and 3]
Participants received oral doses of placebo QD for 14 Days.
|
Part C - 100 mg LY3509754 QD [Cohort 1]
Participants received oral doses of 100 mg LY3509754 QD for 14 Days.
|
Part C - 1.2 mg Midazolam (Day -2) [Cohort 2]
Participants received 1.2 mg midazolam as an oral solution on Day -2.
|
Part C - Placebo QD (Days 1 to 14) [Cohort 2]
Participants received oral doses of placebo QD for 14 Days upon receiving 1.2 mg midazolam on Day -2.
|
Part C - 300 mg LY3509754 QD (Days 1 to 14) [Cohort 2]
Participants received oral doses 300 mg of LY3509754 QD for 14 Days upon receiving 1.2 mg midazolam on Day -2.
|
Part C - Placebo QD + 1.2 mg Midazolam (Day 15) [Cohort 2]
Participants received a single oral dose of placebo QD along with 1.2 mg midazolam given as oral solution on Day 15.
|
Part C - 300 mg LY3509754 QD + 1.2 mg Midazolam (Day 15) [Cohort 2]
Participants received a single oral dose of 300 mg LY3509754 QD along with 1.2 mg midazolam given as oral solution on Day 15.
|
Part C - 1000 mg LY3509754 QD [Cohort 3]
Participants received oral doses of 1000 mg LY3509754 QD for 14 Days.
|
Part D (Japanese) - Placebo QD
Participants received oral doses of placebo QD for 14 Days.
|
Part D (Japanese) - 400 mg LY3509754 QD
Participants received oral doses of 400 mg LY3509754 QD for 14 Days.
|
Part D (Japanese) - 1000 mg LY3509754 QD
Participants received oral doses of 1000 mg LY3509754 QD for 14 Days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3509754 in Parts A and B
|
20.4 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 28
|
49.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 26
|
136 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 73
|
384 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 62
|
278 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 72
|
1390 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 55
|
2310 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 13
|
15.7 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 24
|
43.3 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 41
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part C-Cohorts 1 and 3: P,0.5,1,2,3,4,6,8,12,16,24,48,72,96 h Post Day 14 dose. Part C-Cohort 2: P,0.5,1,2,3,4,5,6,8,12,16,24 h Post Day 14 dose. Part D: P,0.5,1,2,3,4,6,8,12,16,24,48,72,96 h Post Day 14 dose.Population: All participants who received at least one dose of LY3509754 or midazolam and had evaluable PK data.
PK: Cmax of LY3509754 in Parts C and D.
Outcome measures
| Measure |
Part A - Placebo (Fasted)
n=5 Participants
Participants received single oral dose of placebo under fasting condition.
|
Part A - Placebo (Fed)
n=8 Participants
Participants received single oral dose of placebo under fed condition.
|
Part A - 10 Milligram (mg) LY3509754 (Fasted)
n=6 Participants
Participants received a single oral dose of 10 mg LY3509754 under fasting condition.
|
Part A - 30 mg LY3509754 (Fasted)
n=6 Participants
Participants received a single oral dose of 30 mg LY3509754 under fasting condition.
|
Part A - 100 mg LY3509754 (Fasted)
n=6 Participants
Participants received a single oral dose of 100 mg LY3509754 under fasting condition.
|
Part A - 300 mg LY3509754 (Fasted)
Participants received a single oral dose of 300 mg LY3509754 under fasting condition.
|
Part A - 300 mg LY3509754 (Fed)
Participants received a single oral dose of 300 mg LY3509754 under fed condition.
|
Part A - 1000 mg LY3509754 (Fasted)
Participants received a single oral dose of 1000 mg LY3509754 under fasting condition.
|
Part A - 2000 mg LY3509754 (Fasted)
Participants received a single oral dose of 2000 mg LY3509754 under fasting condition.
|
Part B - Placebo Alone (Day 1)
Participants received a single oral dose of placebo on Day 1.
|
Part B - Placebo + 200 mg Itraconazole (Day 10)
Participants received a single oral dose of placebo and 200 mg itraconazole oral solution on Day 10.
|
Part B - 200 mg Itraconazole (Days 4 to 13)
Participants received 200 mg itraconazole as an oral solution BID on Day 4 and QD on Days 5 through 13.
|
Part B - 10 mg LY3509754 Alone (Day 1)
Participants received a single oral dose of 10 mg LY3509754 on Day 1.
|
Part B - 10 mg LY3509754 + 200 mg Itraconazole (Day 10)
Participants received a single oral dose of 10 mg LY3509754 and 200 mg itraconazole oral solution on Day 10.
|
Part C - Placebo QD [Cohorts 1 and 3]
Participants received oral doses of placebo QD for 14 Days.
|
Part C - 100 mg LY3509754 QD [Cohort 1]
Participants received oral doses of 100 mg LY3509754 QD for 14 Days.
|
Part C - 1.2 mg Midazolam (Day -2) [Cohort 2]
Participants received 1.2 mg midazolam as an oral solution on Day -2.
|
Part C - Placebo QD (Days 1 to 14) [Cohort 2]
Participants received oral doses of placebo QD for 14 Days upon receiving 1.2 mg midazolam on Day -2.
|
Part C - 300 mg LY3509754 QD (Days 1 to 14) [Cohort 2]
Participants received oral doses 300 mg of LY3509754 QD for 14 Days upon receiving 1.2 mg midazolam on Day -2.
|
Part C - Placebo QD + 1.2 mg Midazolam (Day 15) [Cohort 2]
Participants received a single oral dose of placebo QD along with 1.2 mg midazolam given as oral solution on Day 15.
|
Part C - 300 mg LY3509754 QD + 1.2 mg Midazolam (Day 15) [Cohort 2]
Participants received a single oral dose of 300 mg LY3509754 QD along with 1.2 mg midazolam given as oral solution on Day 15.
|
Part C - 1000 mg LY3509754 QD [Cohort 3]
Participants received oral doses of 1000 mg LY3509754 QD for 14 Days.
|
Part D (Japanese) - Placebo QD
Participants received oral doses of placebo QD for 14 Days.
|
Part D (Japanese) - 400 mg LY3509754 QD
Participants received oral doses of 400 mg LY3509754 QD for 14 Days.
|
Part D (Japanese) - 1000 mg LY3509754 QD
Participants received oral doses of 1000 mg LY3509754 QD for 14 Days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Cmax of LY3509754 in Parts C and D
|
218 ng/mL
Geometric Coefficient of Variation 52
|
458 ng/mL
Geometric Coefficient of Variation 50
|
1160 ng/mL
Geometric Coefficient of Variation 55
|
805 ng/mL
Geometric Coefficient of Variation 30
|
2050 ng/mL
Geometric Coefficient of Variation 31
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: P, 0.5,1,2,3,4,5,6,8,12,16,24 h post Day 1 dose. Part B: P,0.5,1,2,3,4,6,8,12,16,24 h post Day 1 dose; P,0.5,1,2,3,4,6,8,12,16,24 h Post Day 10 dose.Population: All participants who received at least one dose of LY3509754 or itraconazole and had evaluable PK data.
PK: AUC(0-24) of LY3509754 in Parts A and B.
Outcome measures
| Measure |
Part A - Placebo (Fasted)
n=6 Participants
Participants received single oral dose of placebo under fasting condition.
|
Part A - Placebo (Fed)
n=6 Participants
Participants received single oral dose of placebo under fed condition.
|
Part A - 10 Milligram (mg) LY3509754 (Fasted)
n=6 Participants
Participants received a single oral dose of 10 mg LY3509754 under fasting condition.
|
Part A - 30 mg LY3509754 (Fasted)
n=9 Participants
Participants received a single oral dose of 30 mg LY3509754 under fasting condition.
|
Part A - 100 mg LY3509754 (Fasted)
n=9 Participants
Participants received a single oral dose of 100 mg LY3509754 under fasting condition.
|
Part A - 300 mg LY3509754 (Fasted)
n=6 Participants
Participants received a single oral dose of 300 mg LY3509754 under fasting condition.
|
Part A - 300 mg LY3509754 (Fed)
n=6 Participants
Participants received a single oral dose of 300 mg LY3509754 under fed condition.
|
Part A - 1000 mg LY3509754 (Fasted)
n=8 Participants
Participants received a single oral dose of 1000 mg LY3509754 under fasting condition.
|
Part A - 2000 mg LY3509754 (Fasted)
n=8 Participants
Participants received a single oral dose of 2000 mg LY3509754 under fasting condition.
|
Part B - Placebo Alone (Day 1)
Participants received a single oral dose of placebo on Day 1.
|
Part B - Placebo + 200 mg Itraconazole (Day 10)
Participants received a single oral dose of placebo and 200 mg itraconazole oral solution on Day 10.
|
Part B - 200 mg Itraconazole (Days 4 to 13)
Participants received 200 mg itraconazole as an oral solution BID on Day 4 and QD on Days 5 through 13.
|
Part B - 10 mg LY3509754 Alone (Day 1)
Participants received a single oral dose of 10 mg LY3509754 on Day 1.
|
Part B - 10 mg LY3509754 + 200 mg Itraconazole (Day 10)
Participants received a single oral dose of 10 mg LY3509754 and 200 mg itraconazole oral solution on Day 10.
|
Part C - Placebo QD [Cohorts 1 and 3]
Participants received oral doses of placebo QD for 14 Days.
|
Part C - 100 mg LY3509754 QD [Cohort 1]
Participants received oral doses of 100 mg LY3509754 QD for 14 Days.
|
Part C - 1.2 mg Midazolam (Day -2) [Cohort 2]
Participants received 1.2 mg midazolam as an oral solution on Day -2.
|
Part C - Placebo QD (Days 1 to 14) [Cohort 2]
Participants received oral doses of placebo QD for 14 Days upon receiving 1.2 mg midazolam on Day -2.
|
Part C - 300 mg LY3509754 QD (Days 1 to 14) [Cohort 2]
Participants received oral doses 300 mg of LY3509754 QD for 14 Days upon receiving 1.2 mg midazolam on Day -2.
|
Part C - Placebo QD + 1.2 mg Midazolam (Day 15) [Cohort 2]
Participants received a single oral dose of placebo QD along with 1.2 mg midazolam given as oral solution on Day 15.
|
Part C - 300 mg LY3509754 QD + 1.2 mg Midazolam (Day 15) [Cohort 2]
Participants received a single oral dose of 300 mg LY3509754 QD along with 1.2 mg midazolam given as oral solution on Day 15.
|
Part C - 1000 mg LY3509754 QD [Cohort 3]
Participants received oral doses of 1000 mg LY3509754 QD for 14 Days.
|
Part D (Japanese) - Placebo QD
Participants received oral doses of placebo QD for 14 Days.
|
Part D (Japanese) - 400 mg LY3509754 QD
Participants received oral doses of 400 mg LY3509754 QD for 14 Days.
|
Part D (Japanese) - 1000 mg LY3509754 QD
Participants received oral doses of 1000 mg LY3509754 QD for 14 Days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours Post-dose AUC(0-24) of LY3509754 in Parts A and B
|
153 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 20
|
375 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 25
|
1340 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 60
|
3930 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 45
|
2930 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 69
|
14900 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 42
|
26300 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 29
|
135 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 29
|
596 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 33
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part C-Cohorts 1 and 3: P,0.5,1,2,3,4,6,8,12,16,24 h Post Day 14 dose. Part C-Cohort 2: P,0.5,1,2,3,4,5,6,8,12,16,24 h Post Day 14 dose. Part D: P,0.5,1,2,3,4,6,8,12,16,24 h Post Day 14 dose.Population: All participants who received at least one dose of LY3509754 or midazolam and had evaluable PK data.
PK: AUC(0-24) of LY3509754 in Parts C and D.
Outcome measures
| Measure |
Part A - Placebo (Fasted)
n=5 Participants
Participants received single oral dose of placebo under fasting condition.
|
Part A - Placebo (Fed)
n=8 Participants
Participants received single oral dose of placebo under fed condition.
|
Part A - 10 Milligram (mg) LY3509754 (Fasted)
n=6 Participants
Participants received a single oral dose of 10 mg LY3509754 under fasting condition.
|
Part A - 30 mg LY3509754 (Fasted)
n=6 Participants
Participants received a single oral dose of 30 mg LY3509754 under fasting condition.
|
Part A - 100 mg LY3509754 (Fasted)
n=6 Participants
Participants received a single oral dose of 100 mg LY3509754 under fasting condition.
|
Part A - 300 mg LY3509754 (Fasted)
Participants received a single oral dose of 300 mg LY3509754 under fasting condition.
|
Part A - 300 mg LY3509754 (Fed)
Participants received a single oral dose of 300 mg LY3509754 under fed condition.
|
Part A - 1000 mg LY3509754 (Fasted)
Participants received a single oral dose of 1000 mg LY3509754 under fasting condition.
|
Part A - 2000 mg LY3509754 (Fasted)
Participants received a single oral dose of 2000 mg LY3509754 under fasting condition.
|
Part B - Placebo Alone (Day 1)
Participants received a single oral dose of placebo on Day 1.
|
Part B - Placebo + 200 mg Itraconazole (Day 10)
Participants received a single oral dose of placebo and 200 mg itraconazole oral solution on Day 10.
|
Part B - 200 mg Itraconazole (Days 4 to 13)
Participants received 200 mg itraconazole as an oral solution BID on Day 4 and QD on Days 5 through 13.
|
Part B - 10 mg LY3509754 Alone (Day 1)
Participants received a single oral dose of 10 mg LY3509754 on Day 1.
|
Part B - 10 mg LY3509754 + 200 mg Itraconazole (Day 10)
Participants received a single oral dose of 10 mg LY3509754 and 200 mg itraconazole oral solution on Day 10.
|
Part C - Placebo QD [Cohorts 1 and 3]
Participants received oral doses of placebo QD for 14 Days.
|
Part C - 100 mg LY3509754 QD [Cohort 1]
Participants received oral doses of 100 mg LY3509754 QD for 14 Days.
|
Part C - 1.2 mg Midazolam (Day -2) [Cohort 2]
Participants received 1.2 mg midazolam as an oral solution on Day -2.
|
Part C - Placebo QD (Days 1 to 14) [Cohort 2]
Participants received oral doses of placebo QD for 14 Days upon receiving 1.2 mg midazolam on Day -2.
|
Part C - 300 mg LY3509754 QD (Days 1 to 14) [Cohort 2]
Participants received oral doses 300 mg of LY3509754 QD for 14 Days upon receiving 1.2 mg midazolam on Day -2.
|
Part C - Placebo QD + 1.2 mg Midazolam (Day 15) [Cohort 2]
Participants received a single oral dose of placebo QD along with 1.2 mg midazolam given as oral solution on Day 15.
|
Part C - 300 mg LY3509754 QD + 1.2 mg Midazolam (Day 15) [Cohort 2]
Participants received a single oral dose of 300 mg LY3509754 QD along with 1.2 mg midazolam given as oral solution on Day 15.
|
Part C - 1000 mg LY3509754 QD [Cohort 3]
Participants received oral doses of 1000 mg LY3509754 QD for 14 Days.
|
Part D (Japanese) - Placebo QD
Participants received oral doses of placebo QD for 14 Days.
|
Part D (Japanese) - 400 mg LY3509754 QD
Participants received oral doses of 400 mg LY3509754 QD for 14 Days.
|
Part D (Japanese) - 1000 mg LY3509754 QD
Participants received oral doses of 1000 mg LY3509754 QD for 14 Days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: AUC(0-24) of LY3509754 in Parts C and D
|
2170 ng*h/mL
Geometric Coefficient of Variation 41
|
4050 ng*h/mL
Geometric Coefficient of Variation 38
|
12200 ng*h/mL
Geometric Coefficient of Variation 42
|
7560 ng*h/mL
Geometric Coefficient of Variation 30
|
18000 ng*h/mL
Geometric Coefficient of Variation 22
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A - Placebo (Fasted)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A - Placebo (Fed)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A - 10 Milligram (mg) LY3509754 (Fasted)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A - 30 mg LY3509754 (Fasted)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A - 100 mg LY3509754 (Fasted)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A - 300 mg LY3509754 (Fasted)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A - 300 mg LY3509754 (Fed)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A - 1000 mg LY3509754 (Fasted)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A - 2000 mg LY3509754 (Fasted)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B - Placebo Alone (Day 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B - Placebo + 200 mg Itraconazole (Day 10)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B - 200 mg Itraconazole (Days 4 to 13)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part B - 10 mg LY3509754 Alone (Day 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B - 10 mg LY3509754 + 200 mg Itraconazole (Day 10)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part C - Placebo QD [Cohorts 1 and 3]
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part C - 100 mg LY3509754 QD [Cohort 1]
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part C - 1.2 mg Midazolam (Day -2) [Cohort 2]
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part C - Placebo QD (Days 1 to 14) [Cohort 2]
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part C - 300 mg LY3509754 QD (Days 1 to 14) [Cohort 2]
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part C - Placebo QD + 1.2 mg Midazolam (Day 15) [Cohort 2]
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part C - 300 mg LY3509754 QD + 1.2 mg Midazolam (Day 15) [Cohort 2]
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part C - 1000 mg LY3509754 QD [Cohort 3]
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part D (Japanese) - Placebo QD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part D (Japanese) - 400 mg LY3509754 QD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part D (Japanese) - 1000 mg LY3509754 QD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A - Placebo (Fasted)
n=10 participants at risk
Participants received single oral dose of placebo under fasting condition.
|
Part A - Placebo (Fed)
n=2 participants at risk
Participants received single oral dose of placebo under fed condition.
|
Part A - 10 Milligram (mg) LY3509754 (Fasted)
n=6 participants at risk
Participants received a single oral dose of 10 mg LY3509754 under fasting condition.
|
Part A - 30 mg LY3509754 (Fasted)
n=6 participants at risk
Participants received a single oral dose of 30 mg LY3509754 under fasting condition.
|
Part A - 100 mg LY3509754 (Fasted)
n=6 participants at risk
Participants received a single oral dose of 100 mg LY3509754 under fasting condition.
|
Part A - 300 mg LY3509754 (Fasted)
n=9 participants at risk
Participants received a single oral dose of 300 mg LY3509754 under fasting condition.
|
Part A - 300 mg LY3509754 (Fed)
n=9 participants at risk
Participants received a single oral dose of 300 mg LY3509754 under fed condition.
|
Part A - 1000 mg LY3509754 (Fasted)
n=6 participants at risk
Participants received a single oral dose of 1000 mg LY3509754 under fasting condition.
|
Part A - 2000 mg LY3509754 (Fasted)
n=6 participants at risk
Participants received a single oral dose of 2000 mg LY3509754 under fasting condition.
|
Part B - Placebo Alone (Day 1)
n=3 participants at risk
Participants received a single oral dose of placebo on Day 1.
|
Part B - Placebo + 200 mg Itraconazole (Day 10)
n=3 participants at risk
Participants received a single oral dose of placebo and 200 mg itraconazole oral solution on Day 10.
|
Part B - 200 mg Itraconazole (Days 4 to 13)
n=11 participants at risk
Participants received 200 mg itraconazole as an oral solution BID on Day 4 and QD on Days 5 through 13.
|
Part B - 10 mg LY3509754 Alone (Day 1)
n=8 participants at risk
Participants received a single oral dose of 10 mg LY3509754 on Day 1.
|
Part B - 10 mg LY3509754 + 200 mg Itraconazole (Day 10)
n=8 participants at risk
Participants received a single oral dose of 10 mg LY3509754 and 200 mg itraconazole oral solution on Day 10.
|
Part C - Placebo QD [Cohorts 1 and 3]
n=4 participants at risk
Participants received oral doses of placebo QD for 14 Days.
|
Part C - 100 mg LY3509754 QD [Cohort 1]
n=6 participants at risk
Participants received oral doses of 100 mg LY3509754 QD for 14 Days.
|
Part C - 1.2 mg Midazolam (Day -2) [Cohort 2]
n=10 participants at risk
Participants received 1.2 mg midazolam as an oral solution on Day -2.
|
Part C - Placebo QD (Days 1 to 14) [Cohort 2]
n=2 participants at risk
Participants received oral doses of placebo QD for 14 Days upon receiving 1.2 mg midazolam on Day -2.
|
Part C - 300 mg LY3509754 QD (Days 1 to 14) [Cohort 2]
n=8 participants at risk
Participants received oral doses of 300 mg LY3509754 QD for 14 Days upon receiving 1.2 mg midazolam on Day -2.
|
Part C - Placebo QD + 1.2 mg Midazolam (Day 15) [Cohort 2]
n=2 participants at risk
Participants received a single oral dose of placebo QD along with 1.2 mg midazolam given as oral solution on Day 15.
|
Part C - 300 mg LY3509754 QD + 1.2 mg Midazolam (Day 15) [Cohort 2]
n=8 participants at risk
Participants received a single oral dose of 300 mg LY3509754 QD along with 1.2 mg midazolam given as oral solution on Day 15.
|
Part C - 1000 mg LY3509754 QD [Cohort 3]
n=6 participants at risk
Participants received oral doses of 1000 mg LY3509754 QD for 14 Days.
|
Part D (Japanese) - Placebo QD
n=4 participants at risk
Participants received oral doses of placebo QD for 15 Days.
|
Part D (Japanese) - 400 mg LY3509754 QD
n=6 participants at risk
Participants received oral doses of 400 mg LY3509754 QD for 15 Days.
|
Part D (Japanese) - 1000 mg LY3509754 QD
n=6 participants at risk
Participants received oral doses of 1000 mg LY3509754 QD for 15 Days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
50.0%
2/4 • Number of events 3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
66.7%
4/6 • Number of events 5 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.3%
2/6 • Number of events 3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
27.3%
3/11 • Number of events 3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Saliva altered
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Medical device site irritation
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Sensation of foreign body
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.5%
1/8 • Number of events 2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
50.0%
3/6 • Number of events 3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
50.0%
1/2 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Hepatitis e
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Gingival injury
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.1%
1/11 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Influenza b virus test positive
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Transaminases increased
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
100.0%
1/1 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60