Trial Outcomes & Findings for A Study of LY3526318 in Healthy Participants (NCT NCT03977974)
NCT ID: NCT03977974
Last Updated: 2025-09-12
Results Overview
An SAE is any AE from this 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 and important medical events that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent 1 of the other outcomes listed in the definition. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, are reported in the Adverse Events module section.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
76 participants
Primary outcome timeframe
Baseline Up To 32 Days
Results posted on
2025-09-12
Participant Flow
This study consists of 2 parts: * Part A: Single-ascending dose (SAD, \[including a food effect (FE)\]). * Part B: Multiple-ascending dose (MAD). Both parts were randomized, double-blind, and placebo-controlled, with the exception of the 100 milligram (mg) FE part.
Participant milestones
| Measure |
SAD: Placebo
Participants received placebo administered orally.
|
SAD: 10 mg LY3526318
Participants received 10 mg LY3526318 administered orally.
|
SAD: 30 mg LY3526318
Participants received 30 mg LY3526318 administered orally.
|
SAD: 50 mg LY3526318
Participants received 50 mg LY3526318 administered orally.
|
SAD: 100 mg LY3526318 (Fasted) and 30 mg LY3526318 (Fed)
Period 1:
Participants received 100 mg LY3526318 administered orally without a meal.
Period 2:
Participants received 30 mg LY3526318 administered orally with a meal.
|
SAD: 200 mg LY3526318 (Fasted) and 200 mg LY3526318 (Fed)
Period 1:
Participants received 200 mg LY3526318 administered orally without a meal.
Period 2:
Participants received 200 mg LY3526318 administered orally with a meal.
|
SAD: 300 mg LY3526318
Participants received 300 mg LY3526318 administered orally.
|
SAD: 100 mg LY3526318 Fed
Period 1: Participants received 100 mg LY3526318 administered orally 30 minutes after breakfast (Fed \[-30 min.\])
Period 2:
Participants received 100 mg LY3526318 orally 30 minutes before breakfast (Fed \[+30 min.\])
Period 3: Participants received 100 mg LY3526318 administered orally 60 minutes before breakfast (Fed \[+60 min.\])
|
SAD: Placebo Fed
Period 1: Participants received placebo administered orally 30 minutes after breakfast (Fed \[-30 min.\])
Period 2:
Participants received placebo administered orally 30 minutes before breakfast (Fed \[+30 min.\])
Period 3: Participants received placebo administered orally 60 minutes before breakfast (Fed \[+60 min.\])
|
MAD: Placebo QD
Participants received placebo once daily (QD) administered orally for 14 days.
|
MAD: 30 mg LY3526318 QD
Participants received 30 mg LY3526318 QD administered orally for 14 days.
|
MAD: 60 mg LY3526318 QD
Participants received 60 mg LY3526318 QD administered orally for 14 days.
|
MAD: 100 mg LY352631 QD
Participants received 100 mg LY3526318 QD administered orally for 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
12
|
6
|
6
|
6
|
6
|
6
|
6
|
3
|
1
|
6
|
6
|
6
|
6
|
|
Period 1
Received at Least One Dose of Study Drug
|
12
|
6
|
6
|
6
|
6
|
6
|
6
|
3
|
1
|
6
|
6
|
6
|
6
|
|
Period 1
COMPLETED
|
12
|
6
|
6
|
6
|
6
|
6
|
6
|
3
|
1
|
6
|
6
|
6
|
6
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
0
|
0
|
0
|
0
|
6
|
6
|
0
|
3
|
1
|
0
|
0
|
0
|
0
|
|
Period 2
COMPLETED
|
0
|
0
|
0
|
0
|
5
|
6
|
0
|
3
|
1
|
0
|
0
|
0
|
0
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
0
|
0
|
0
|
0
|
|
Period 3
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
0
|
0
|
0
|
0
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
SAD: Placebo
Participants received placebo administered orally.
|
SAD: 10 mg LY3526318
Participants received 10 mg LY3526318 administered orally.
|
SAD: 30 mg LY3526318
Participants received 30 mg LY3526318 administered orally.
|
SAD: 50 mg LY3526318
Participants received 50 mg LY3526318 administered orally.
|
SAD: 100 mg LY3526318 (Fasted) and 30 mg LY3526318 (Fed)
Period 1:
Participants received 100 mg LY3526318 administered orally without a meal.
Period 2:
Participants received 30 mg LY3526318 administered orally with a meal.
|
SAD: 200 mg LY3526318 (Fasted) and 200 mg LY3526318 (Fed)
Period 1:
Participants received 200 mg LY3526318 administered orally without a meal.
Period 2:
Participants received 200 mg LY3526318 administered orally with a meal.
|
SAD: 300 mg LY3526318
Participants received 300 mg LY3526318 administered orally.
|
SAD: 100 mg LY3526318 Fed
Period 1: Participants received 100 mg LY3526318 administered orally 30 minutes after breakfast (Fed \[-30 min.\])
Period 2:
Participants received 100 mg LY3526318 orally 30 minutes before breakfast (Fed \[+30 min.\])
Period 3: Participants received 100 mg LY3526318 administered orally 60 minutes before breakfast (Fed \[+60 min.\])
|
SAD: Placebo Fed
Period 1: Participants received placebo administered orally 30 minutes after breakfast (Fed \[-30 min.\])
Period 2:
Participants received placebo administered orally 30 minutes before breakfast (Fed \[+30 min.\])
Period 3: Participants received placebo administered orally 60 minutes before breakfast (Fed \[+60 min.\])
|
MAD: Placebo QD
Participants received placebo once daily (QD) administered orally for 14 days.
|
MAD: 30 mg LY3526318 QD
Participants received 30 mg LY3526318 QD administered orally for 14 days.
|
MAD: 60 mg LY3526318 QD
Participants received 60 mg LY3526318 QD administered orally for 14 days.
|
MAD: 100 mg LY352631 QD
Participants received 100 mg LY3526318 QD administered orally for 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Period 2
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of LY3526318 in Healthy Participants
Baseline characteristics by cohort
| Measure |
SAD: Placebo
n=12 Participants
Participants received placebo administered orally.
|
SAD: 10 mg LY3526318
n=6 Participants
Participants received 10 mg LY3526318 administered orally..
|
SAD: 30 mg LY3526318
n=6 Participants
Participants received 30 mg LY3526318 administered orally.
|
SAD: 50 mg LY3526318
n=6 Participants
Participants received 50 mg LY3526318 administered orally.
|
SAD: 100 mg LY3526318 (Fasted) and 30 mg LY3526318 (Fed)
n=6 Participants
Period 1:
Participants received 100 mg LY3526318 administered orally without a meal.
Period 2:
Participants received 30 mg LY3526318 administered orally with a meal.
|
SAD: 200 mg LY3526318 (Fasted) and 200 mg LY3526318 (Fed)
n=6 Participants
Period 1:
Participants received 200 mg LY3526318 administered orally without a meal.
Period 2:
Participants received 200 mg LY3526318 administered orally with a meal.
|
SAD: 300 mg LY3526318
n=6 Participants
Participants received 300 mg LY3526318 administered orally.
|
SAD: 100 mg LY3526318 Fed
n=3 Participants
Period 1: Participants received 100 mg LY3526318 administered orally 30 minutes after breakfast (Fed \[-30 min.\])
Period 2:
Participants received 100 mg LY3526318 orally 30 minutes before breakfast (Fed \[+30 min.\])
Period 3: Participants received 100 mg LY3526318 administered orally 60 minutes before breakfast (Fed \[+60 min.\])
|
SAD: Placebo Fed
n=1 Participants
Period 1: Participants received placebo administered orally 30 minutes after breakfast (Fed \[-30 min.\])
Period 2:
Participants received placebo administered orally 30 minutes before breakfast (Fed \[+30 min.\])
Period 3: Participants received placebo administered orally 60 minutes before breakfast (Fed \[+60 min.\])
|
MAD: Placebo QD
n=6 Participants
Participants received placebo one daily (QD) administered orally for 14 days.
|
MAD: 30 mg LY3526318 QD
n=6 Participants
Participants received 30 mg LY3526318 QD administered orally for 14 days.
|
MAD: 60 mg LY3526318 QD
n=6 Participants
Participants received 60 mg LY3526318 QD administered orally for 14 days.
|
MAD: 100 mg LY352631 QD
n=6 Participants
Participants received 100 mg LY3526318 QD administered orally for 14 days
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION 17 • n=93 Participants
|
41 years
STANDARD_DEVIATION 20 • n=4 Participants
|
30 years
STANDARD_DEVIATION 17 • n=27 Participants
|
26 years
STANDARD_DEVIATION 3 • n=483 Participants
|
36 years
STANDARD_DEVIATION 20 • n=36 Participants
|
39 years
STANDARD_DEVIATION 14 • n=10 Participants
|
40 years
STANDARD_DEVIATION 19 • n=115 Participants
|
46 years
STANDARD_DEVIATION 21 • n=40 Participants
|
49 years
STANDARD_DEVIATION NA • n=8 Participants
|
35 years
STANDARD_DEVIATION 8 • n=62 Participants
|
38 years
STANDARD_DEVIATION 14 • n=95 Participants
|
29 years
STANDARD_DEVIATION 14 • n=129 Participants
|
35 years
STANDARD_DEVIATION 15 • n=36 Participants
|
35.09 years
STANDARD_DEVIATION 15.31 • n=36 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=62 Participants
|
6 Participants
n=95 Participants
|
6 Participants
n=129 Participants
|
6 Participants
n=36 Participants
|
70 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
6 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
1 Participants
n=36 Participants
|
6 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=62 Participants
|
5 Participants
n=95 Participants
|
6 Participants
n=129 Participants
|
5 Participants
n=36 Participants
|
70 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
2 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
1 Participants
n=36 Participants
|
5 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
1 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=62 Participants
|
4 Participants
n=95 Participants
|
5 Participants
n=129 Participants
|
4 Participants
n=36 Participants
|
60 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
1 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
6 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
Netherlands
|
12 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=62 Participants
|
6 Participants
n=95 Participants
|
6 Participants
n=129 Participants
|
6 Participants
n=36 Participants
|
76 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline Up To 32 DaysPopulation: All participants who received at least one dose of study drug.
An SAE is any AE from this 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 and important medical events that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent 1 of the other outcomes listed in the definition. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, are reported in the Adverse Events module section.
Outcome measures
| Measure |
SAD: Placebo
n=12 Participants
Participants received placebo administered orally.
|
SAD: 10 mg LY3526318
n=6 Participants
Participants received 10 mg LY3526318 administered orally.
|
SAD: 30 mg LY3526318
n=6 Participants
Participants received 30 mg LY3526318 administered orally.
|
SAD: 50 mg LY3526318
n=6 Participants
Participants received 50 mg LY3526318 orally.
|
SAD: 100 mg LY3526318 (Fasted) and 30 mg LY3526318 (Fed)
n=6 Participants
Period 1:
Participants received 100 mg LY3526318 administered orally without a meal.
Period 2:
Participants received 30 mg LY3526318 administered orally with a meal.
|
SAD: 200 mg LY3526318 (Fasted) and 200 mg LY3526318 (Fed)
n=6 Participants
Period 1:
Participants received 200 mg LY3526318 administered orally without a meal.
Period 2:
Participants received 200 mg LY3526318 administered orally with a meal.
|
SAD: 300 mg LY3526318
n=6 Participants
Participants received 300 mg LY3526318 administered orally.
|
SAD: 100 mg LY3526318 Fed
n=3 Participants
Period 1: Participants received 100 mg LY3526318 administered orally 30 minutes after breakfast (Fed \[-30 min.\])
Period 2:
Participants received 100 mg LY3526318 orally 30 minutes before breakfast (Fed \[+30 min.\])
Period 3: Participants received 100 mg LY3526318 administered orally 60 minutes before breakfast (Fed \[+60 min.\])
|
SAD: Placebo Fed
n=1 Participants
Period 1: Participants received placebo administered orally 30 minutes after breakfast (Fed \[-30 min.\])
Period 2:
Participants received placebo administered orally 30 minutes before breakfast (Fed \[+30 min.\])
Period 3: Participants received placebo administered orally 60 minutes before breakfast (Fed \[+60 min.\])
|
MAD: Placebo QD
n=6 Participants
Participants received placebo one daily (QD) orally for 14 days.
|
MAD: 30 mg LY3526318 QD
n=6 Participants
Participants received 30 mg LY3526318 QD administered orally for 14 days.
|
MAD: 60 mg LY3526318 QD
n=6 Participants
Participants received 60 mg LY3526318 QD administered orally for 14 days.
|
MAD: 100 mg LY352631 QD
n=6 Participants
Participants received 100 mg LY3526318 QD administered orally 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
|
SECONDARY outcome
Timeframe: SAD: Day 1: predose, 1, 2, 4, 6, 8 and 12 hours postdose; Day 2 and Day 3: 24 and 48 hours postdose; 3-Period Food Effect Arms: Day 1: Predose, 1, 2, 4, 6, 8 and 12 hours, Day 2, Day 3 and Day 4: Predose, 24, 48 and 72 hours postdosePopulation: SAD: All participants who received at least one dose of study drug and had evaluable PK data.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC\[0-∞\]) of LY3526318
Outcome measures
| Measure |
SAD: Placebo
n=6 Participants
Participants received placebo administered orally.
|
SAD: 10 mg LY3526318
n=6 Participants
Participants received 10 mg LY3526318 administered orally.
|
SAD: 30 mg LY3526318
n=6 Participants
Participants received 30 mg LY3526318 administered orally.
|
SAD: 50 mg LY3526318
n=5 Participants
Participants received 50 mg LY3526318 orally.
|
SAD: 100 mg LY3526318 (Fasted) and 30 mg LY3526318 (Fed)
n=4 Participants
Period 1:
Participants received 100 mg LY3526318 administered orally without a meal.
Period 2:
Participants received 30 mg LY3526318 administered orally with a meal.
|
SAD: 200 mg LY3526318 (Fasted) and 200 mg LY3526318 (Fed)
n=6 Participants
Period 1:
Participants received 200 mg LY3526318 administered orally without a meal.
Period 2:
Participants received 200 mg LY3526318 administered orally with a meal.
|
SAD: 300 mg LY3526318
n=1 Participants
Participants received 300 mg LY3526318 administered orally.
|
SAD: 100 mg LY3526318 Fed
n=4 Participants
Period 1: Participants received 100 mg LY3526318 administered orally 30 minutes after breakfast (Fed \[-30 min.\])
Period 2:
Participants received 100 mg LY3526318 orally 30 minutes before breakfast (Fed \[+30 min.\])
Period 3: Participants received 100 mg LY3526318 administered orally 60 minutes before breakfast (Fed \[+60 min.\])
|
SAD: Placebo Fed
n=2 Participants
Period 1: Participants received placebo administered orally 30 minutes after breakfast (Fed \[-30 min.\])
Period 2:
Participants received placebo administered orally 30 minutes before breakfast (Fed \[+30 min.\])
Period 3: Participants received placebo administered orally 60 minutes before breakfast (Fed \[+60 min.\])
|
MAD: Placebo QD
n=3 Participants
Participants received placebo one daily (QD) orally for 14 days.
|
MAD: 30 mg LY3526318 QD
n=3 Participants
Participants received 30 mg LY3526318 QD administered orally for 14 days.
|
MAD: 60 mg LY3526318 QD
Participants received 60 mg LY3526318 QD administered orally for 14 days.
|
MAD: 100 mg LY352631 QD
Participants received 100 mg LY3526318 QD administered orally for 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3526318
|
2322 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 64.3
|
6132 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 107.0
|
15442 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 63.6
|
55533 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 56.6
|
45746 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 58.5
|
58311 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 100.3
|
NA nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Geometric mean and coefficient of variation couldn't be calculated as there was only a single participant. Individual value reported = 7058 ng\*h/mL.
|
10603 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 107.0
|
6379 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 47.4
|
19028 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 15.3
|
20237 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 38.8
|
—
|
—
|
SECONDARY outcome
Timeframe: MAD: Day 1: Predose,1, 2, 4, 6, 8 and 12 hours post dosePopulation: MAD: All participants who received at least one dose of study drug and had evaluable PK data.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to 24 hours (AUC\[0-24\]) of LY3526318
Outcome measures
| Measure |
SAD: Placebo
n=6 Participants
Participants received placebo administered orally.
|
SAD: 10 mg LY3526318
n=6 Participants
Participants received 10 mg LY3526318 administered orally.
|
SAD: 30 mg LY3526318
n=6 Participants
Participants received 30 mg LY3526318 administered orally.
|
SAD: 50 mg LY3526318
Participants received 50 mg LY3526318 orally.
|
SAD: 100 mg LY3526318 (Fasted) and 30 mg LY3526318 (Fed)
Period 1:
Participants received 100 mg LY3526318 administered orally without a meal.
Period 2:
Participants received 30 mg LY3526318 administered orally with a meal.
|
SAD: 200 mg LY3526318 (Fasted) and 200 mg LY3526318 (Fed)
Period 1:
Participants received 200 mg LY3526318 administered orally without a meal.
Period 2:
Participants received 200 mg LY3526318 administered orally with a meal.
|
SAD: 300 mg LY3526318
Participants received 300 mg LY3526318 administered orally.
|
SAD: 100 mg LY3526318 Fed
Period 1: Participants received 100 mg LY3526318 administered orally 30 minutes after breakfast (Fed \[-30 min.\])
Period 2:
Participants received 100 mg LY3526318 orally 30 minutes before breakfast (Fed \[+30 min.\])
Period 3: Participants received 100 mg LY3526318 administered orally 60 minutes before breakfast (Fed \[+60 min.\])
|
SAD: Placebo Fed
Period 1: Participants received placebo administered orally 30 minutes after breakfast (Fed \[-30 min.\])
Period 2:
Participants received placebo administered orally 30 minutes before breakfast (Fed \[+30 min.\])
Period 3: Participants received placebo administered orally 60 minutes before breakfast (Fed \[+60 min.\])
|
MAD: Placebo QD
Participants received placebo one daily (QD) orally for 14 days.
|
MAD: 30 mg LY3526318 QD
Participants received 30 mg LY3526318 QD administered orally for 14 days.
|
MAD: 60 mg LY3526318 QD
Participants received 60 mg LY3526318 QD administered orally for 14 days.
|
MAD: 100 mg LY352631 QD
Participants received 100 mg LY3526318 QD administered orally for 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to 24 Hours (AUC[0-24]) of LY3526318
|
6015 ng*h/mL
Geometric Coefficient of Variation 80.7
|
18525 ng*h/mL
Geometric Coefficient of Variation 48.1
|
25769 ng*h/mL
Geometric Coefficient of Variation 68.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SAD: Day 1: predose, 1, 2, 4, 6, 8 and 12 hours postdose; Day 2 and Day 3: 24 and 48 hours postdose; 3-Period Food Effect Arms: Day 1: Predose, 1, 2, 4, 6, 8 and 12 hours, Day 2, Day 3 and Day 4: Predose, 24, 48 and 72 hours postdosePopulation: SAD: All participants who received at least one dose of study drug and had evaluable PK data.
PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
Outcome measures
| Measure |
SAD: Placebo
n=6 Participants
Participants received placebo administered orally.
|
SAD: 10 mg LY3526318
n=6 Participants
Participants received 10 mg LY3526318 administered orally.
|
SAD: 30 mg LY3526318
n=6 Participants
Participants received 30 mg LY3526318 administered orally.
|
SAD: 50 mg LY3526318
n=6 Participants
Participants received 50 mg LY3526318 orally.
|
SAD: 100 mg LY3526318 (Fasted) and 30 mg LY3526318 (Fed)
n=6 Participants
Period 1:
Participants received 100 mg LY3526318 administered orally without a meal.
Period 2:
Participants received 30 mg LY3526318 administered orally with a meal.
|
SAD: 200 mg LY3526318 (Fasted) and 200 mg LY3526318 (Fed)
n=6 Participants
Period 1:
Participants received 200 mg LY3526318 administered orally without a meal.
Period 2:
Participants received 200 mg LY3526318 administered orally with a meal.
|
SAD: 300 mg LY3526318
n=5 Participants
Participants received 300 mg LY3526318 administered orally.
|
SAD: 100 mg LY3526318 Fed
n=6 Participants
Period 1: Participants received 100 mg LY3526318 administered orally 30 minutes after breakfast (Fed \[-30 min.\])
Period 2:
Participants received 100 mg LY3526318 orally 30 minutes before breakfast (Fed \[+30 min.\])
Period 3: Participants received 100 mg LY3526318 administered orally 60 minutes before breakfast (Fed \[+60 min.\])
|
SAD: Placebo Fed
n=3 Participants
Period 1: Participants received placebo administered orally 30 minutes after breakfast (Fed \[-30 min.\])
Period 2:
Participants received placebo administered orally 30 minutes before breakfast (Fed \[+30 min.\])
Period 3: Participants received placebo administered orally 60 minutes before breakfast (Fed \[+60 min.\])
|
MAD: Placebo QD
n=3 Participants
Participants received placebo one daily (QD) orally for 14 days.
|
MAD: 30 mg LY3526318 QD
n=3 Participants
Participants received 30 mg LY3526318 QD administered orally for 14 days.
|
MAD: 60 mg LY3526318 QD
Participants received 60 mg LY3526318 QD administered orally for 14 days.
|
MAD: 100 mg LY352631 QD
Participants received 100 mg LY3526318 QD administered orally for 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
|
188 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 100.7
|
573 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 119.5
|
1321 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 58.9
|
4265 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 60.8
|
5047 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 40.6
|
4879 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 120.8
|
204 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 51.6
|
719 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 139.0
|
378 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 43.3
|
1288 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 34.9
|
1407 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 91.2
|
—
|
—
|
SECONDARY outcome
Timeframe: MAD: Day 1 and Day 14: Predose, 1, 2, 4, 6, 8 and 12 hours post dosePopulation: MAD: All participants who received at least one dose of study drug and had evaluable PK data.
PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
Outcome measures
| Measure |
SAD: Placebo
n=6 Participants
Participants received placebo administered orally.
|
SAD: 10 mg LY3526318
n=6 Participants
Participants received 10 mg LY3526318 administered orally.
|
SAD: 30 mg LY3526318
n=6 Participants
Participants received 30 mg LY3526318 administered orally.
|
SAD: 50 mg LY3526318
Participants received 50 mg LY3526318 orally.
|
SAD: 100 mg LY3526318 (Fasted) and 30 mg LY3526318 (Fed)
Period 1:
Participants received 100 mg LY3526318 administered orally without a meal.
Period 2:
Participants received 30 mg LY3526318 administered orally with a meal.
|
SAD: 200 mg LY3526318 (Fasted) and 200 mg LY3526318 (Fed)
Period 1:
Participants received 200 mg LY3526318 administered orally without a meal.
Period 2:
Participants received 200 mg LY3526318 administered orally with a meal.
|
SAD: 300 mg LY3526318
Participants received 300 mg LY3526318 administered orally.
|
SAD: 100 mg LY3526318 Fed
Period 1: Participants received 100 mg LY3526318 administered orally 30 minutes after breakfast (Fed \[-30 min.\])
Period 2:
Participants received 100 mg LY3526318 orally 30 minutes before breakfast (Fed \[+30 min.\])
Period 3: Participants received 100 mg LY3526318 administered orally 60 minutes before breakfast (Fed \[+60 min.\])
|
SAD: Placebo Fed
Period 1: Participants received placebo administered orally 30 minutes after breakfast (Fed \[-30 min.\])
Period 2:
Participants received placebo administered orally 30 minutes before breakfast (Fed \[+30 min.\])
Period 3: Participants received placebo administered orally 60 minutes before breakfast (Fed \[+60 min.\])
|
MAD: Placebo QD
Participants received placebo one daily (QD) orally for 14 days.
|
MAD: 30 mg LY3526318 QD
Participants received 30 mg LY3526318 QD administered orally for 14 days.
|
MAD: 60 mg LY3526318 QD
Participants received 60 mg LY3526318 QD administered orally for 14 days.
|
MAD: 100 mg LY352631 QD
Participants received 100 mg LY3526318 QD administered orally for 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
Day 1
|
666 ng/mL
Geometric Coefficient of Variation 92.5
|
2117 ng/mL
Geometric Coefficient of Variation 35.7
|
2987 ng/mL
Geometric Coefficient of Variation 60.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
Day 14
|
1017 ng/mL
Geometric Coefficient of Variation 39.7
|
2791 ng/mL
Geometric Coefficient of Variation 63.2
|
4224 ng/mL
Geometric Coefficient of Variation 38.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SAD: Day 1: predose, 1, 2, 4, 6, 8 and 12 hours postdose; Day 2 and Day 3: 24 and 48 hours postdose; 3-Period Food Effect Arms: Day 1: Predose, 1, 2, 4, 6, 8 and 12 hours, Day 2, Day 3 and Day 4: Predose, 24, 48 and 72 hours postdosePopulation: SAD: All participants who received at least one dose of study drug and had evaluable PK data.
PK: Time to Maximum Concentration (Tmax) of LY3526318
Outcome measures
| Measure |
SAD: Placebo
n=6 Participants
Participants received placebo administered orally.
|
SAD: 10 mg LY3526318
n=6 Participants
Participants received 10 mg LY3526318 administered orally.
|
SAD: 30 mg LY3526318
n=6 Participants
Participants received 30 mg LY3526318 administered orally.
|
SAD: 50 mg LY3526318
n=6 Participants
Participants received 50 mg LY3526318 orally.
|
SAD: 100 mg LY3526318 (Fasted) and 30 mg LY3526318 (Fed)
n=6 Participants
Period 1:
Participants received 100 mg LY3526318 administered orally without a meal.
Period 2:
Participants received 30 mg LY3526318 administered orally with a meal.
|
SAD: 200 mg LY3526318 (Fasted) and 200 mg LY3526318 (Fed)
n=6 Participants
Period 1:
Participants received 200 mg LY3526318 administered orally without a meal.
Period 2:
Participants received 200 mg LY3526318 administered orally with a meal.
|
SAD: 300 mg LY3526318
n=5 Participants
Participants received 300 mg LY3526318 administered orally.
|
SAD: 100 mg LY3526318 Fed
n=6 Participants
Period 1: Participants received 100 mg LY3526318 administered orally 30 minutes after breakfast (Fed \[-30 min.\])
Period 2:
Participants received 100 mg LY3526318 orally 30 minutes before breakfast (Fed \[+30 min.\])
Period 3: Participants received 100 mg LY3526318 administered orally 60 minutes before breakfast (Fed \[+60 min.\])
|
SAD: Placebo Fed
n=3 Participants
Period 1: Participants received placebo administered orally 30 minutes after breakfast (Fed \[-30 min.\])
Period 2:
Participants received placebo administered orally 30 minutes before breakfast (Fed \[+30 min.\])
Period 3: Participants received placebo administered orally 60 minutes before breakfast (Fed \[+60 min.\])
|
MAD: Placebo QD
n=3 Participants
Participants received placebo one daily (QD) orally for 14 days.
|
MAD: 30 mg LY3526318 QD
n=3 Participants
Participants received 30 mg LY3526318 QD administered orally for 14 days.
|
MAD: 60 mg LY3526318 QD
Participants received 60 mg LY3526318 QD administered orally for 14 days.
|
MAD: 100 mg LY352631 QD
Participants received 100 mg LY3526318 QD administered orally for 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Time to Maximum Concentration (Tmax) of LY3526318
|
2.03 hours
Interval 2.0 to 4.02
|
2.00 hours
Interval 2.0 to 4.0
|
3.00 hours
Interval 2.0 to 4.0
|
4.00 hours
Interval 2.0 to 4.02
|
4.00 hours
Interval 2.0 to 4.02
|
4.00 hours
Interval 2.0 to 4.0
|
12.00 hours
Interval 4.0 to 24.02
|
4.00 hours
Interval 2.0 to 8.02
|
4.03 hours
Interval 4.03 to 12.0
|
4.00 hours
Interval 1.0 to 4.08
|
4.00 hours
Interval 2.0 to 12.0
|
—
|
—
|
SECONDARY outcome
Timeframe: MAD: Day 1 and Day 14: Predose, 1, 2, 4, 6, 8 and 12 hours post dosePopulation: MAD: All participants who received at least one dose of study drug and had evaluable PK data.
PK: Time to Maximum Concentration (Tmax) of LY3526318
Outcome measures
| Measure |
SAD: Placebo
n=6 Participants
Participants received placebo administered orally.
|
SAD: 10 mg LY3526318
n=6 Participants
Participants received 10 mg LY3526318 administered orally.
|
SAD: 30 mg LY3526318
n=6 Participants
Participants received 30 mg LY3526318 administered orally.
|
SAD: 50 mg LY3526318
Participants received 50 mg LY3526318 orally.
|
SAD: 100 mg LY3526318 (Fasted) and 30 mg LY3526318 (Fed)
Period 1:
Participants received 100 mg LY3526318 administered orally without a meal.
Period 2:
Participants received 30 mg LY3526318 administered orally with a meal.
|
SAD: 200 mg LY3526318 (Fasted) and 200 mg LY3526318 (Fed)
Period 1:
Participants received 200 mg LY3526318 administered orally without a meal.
Period 2:
Participants received 200 mg LY3526318 administered orally with a meal.
|
SAD: 300 mg LY3526318
Participants received 300 mg LY3526318 administered orally.
|
SAD: 100 mg LY3526318 Fed
Period 1: Participants received 100 mg LY3526318 administered orally 30 minutes after breakfast (Fed \[-30 min.\])
Period 2:
Participants received 100 mg LY3526318 orally 30 minutes before breakfast (Fed \[+30 min.\])
Period 3: Participants received 100 mg LY3526318 administered orally 60 minutes before breakfast (Fed \[+60 min.\])
|
SAD: Placebo Fed
Period 1: Participants received placebo administered orally 30 minutes after breakfast (Fed \[-30 min.\])
Period 2:
Participants received placebo administered orally 30 minutes before breakfast (Fed \[+30 min.\])
Period 3: Participants received placebo administered orally 60 minutes before breakfast (Fed \[+60 min.\])
|
MAD: Placebo QD
Participants received placebo one daily (QD) orally for 14 days.
|
MAD: 30 mg LY3526318 QD
Participants received 30 mg LY3526318 QD administered orally for 14 days.
|
MAD: 60 mg LY3526318 QD
Participants received 60 mg LY3526318 QD administered orally for 14 days.
|
MAD: 100 mg LY352631 QD
Participants received 100 mg LY3526318 QD administered orally for 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Time to Maximum Concentration (Tmax) of LY3526318
Day 1
|
4.00 hours
Interval 2.0 to 24.0
|
3.00 hours
Interval 2.0 to 4.02
|
3.00 hours
Interval 2.0 to 4.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK: Time to Maximum Concentration (Tmax) of LY3526318
Day 14
|
4.01 hours
Interval 2.0 to 4.03
|
4.01 hours
Interval 2.0 to 4.03
|
4.00 hours
Interval 2.0 to 4.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
SAD: Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
SAD: 10 mg LY3526318
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SAD: 30 mg LY3526318
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
SAD: 50 mg LY3526318
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SAD: 100 mg LY3526318
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
SAD: 200 mg LY3526318
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SAD: 300 mg LY3526318
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
SAD: Placebo Fed (-30 Min)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SAD: Placebo Fed (+30 Min)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SAD: Placebo Fed (+60 Min)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MAD: Placebo QD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
MAD: 30 mg LY3526318 QD LY3526318 QD
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
MAD: 60 mg LY3526318 QD LY3526318 QD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
MAD: 100 mg LY352631 QD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
SAD: Placebo Fed
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SAD: 30 mg LY3526318 Fed
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SAD: 200 mg LY3526318 Fed
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SAD: 100 mg LY Fed (-30 Min)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
SAD: 100 mg LY Fed (+30 Min)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
SAD:100 mg LY Fed (+60 Min)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SAD: Placebo
n=12 participants at risk
Participants received placebo administered orally.
|
SAD: 10 mg LY3526318
n=6 participants at risk
Participants received 10 mg LY3526318 administered orally.
|
SAD: 30 mg LY3526318
n=6 participants at risk
Participants received 30 mg LY3526318 administered orally.
|
SAD: 50 mg LY3526318
n=6 participants at risk
Participants received 50 mg LY3526318 administered orally.
|
SAD: 100 mg LY3526318
n=6 participants at risk
Participants received 100 mg LY3526318 administered orally without a meal.
|
SAD: 200 mg LY3526318
n=6 participants at risk
Participants received 200 mg LY3526318 administered orally without a meal.
|
SAD: 300 mg LY3526318
n=6 participants at risk
Participants received 300 mg LY3526318 administered orally.
|
SAD: Placebo Fed (-30 Min)
n=1 participants at risk
Participants received placebo administered orally 30 minutes after breakfast (Fed \[-30 min.\]).
|
SAD: Placebo Fed (+30 Min)
n=1 participants at risk
Participants received placebo administered orally 30 minutes before breakfast (Fed \[+30 min.\]).
|
SAD: Placebo Fed (+60 Min)
n=1 participants at risk
Participants received placebo administered orally 60 minutes before breakfast (Fed \[+60 min.\]).
|
MAD: Placebo QD
n=6 participants at risk
Participants received placebo one daily (QD) administered orally for 14 days.
|
MAD: 30 mg LY3526318 QD LY3526318 QD
n=6 participants at risk
Participants received 30 mg LY3526318 QD administered orally for 14 days.
|
MAD: 60 mg LY3526318 QD LY3526318 QD
n=6 participants at risk
Participants received 60 mg LY3526318 QD administered orally for 14 days.
|
MAD: 100 mg LY352631 QD
n=6 participants at risk
Participants received 100 mg LY3526318 QD administered orally for 14 days.
|
SAD: Placebo Fed
n=4 participants at risk
Period 1: Participants received placebo administered orally 30 minutes after breakfast (Fed \[-30 min.\])
Period 2:
Participants received placebo administered orally 30 minutes before breakfast (Fed \[+30 min.\])
Period 3: Participants received placebo administered orally 60 minutes before breakfast (Fed \[+60 min.\])
|
SAD: 30 mg LY3526318 Fed
n=6 participants at risk
Participants received 30 mg LY3526318 administered orally with a meal.
|
SAD: 200 mg LY3526318 Fed
n=6 participants at risk
Participants received 200 mg LY3526318 administered orally with a meal.
|
SAD: 100 mg LY Fed (-30 Min)
n=3 participants at risk
Participants received 100 mg LY3526318 administered orally 30 minutes after breakfast (Fed \[-30 min.\])
|
SAD: 100 mg LY Fed (+30 Min)
n=3 participants at risk
Participants received 100 mg LY3526318 orally 30 minutes before breakfast (Fed \[+30 min.\])
|
SAD:100 mg LY Fed (+60 Min)
n=3 participants at risk
Participants received 100 mg LY3526318 administered orally 60 minutes before breakfast (Fed \[+60 min.\]).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
100.0%
1/1 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
100.0%
1/1 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
66.7%
2/3 • Number of events 2 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Catheter site bruise
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Catheter site related reaction
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Fatigue
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.3%
2/6 • Number of events 3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Feeling cold
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Feeling of body temperature change
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site bruising
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site reaction
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Medical device site reaction
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
8.3%
1/12 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
100.0%
1/1 • Number of events 2 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Burning sensation
|
8.3%
1/12 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Drug withdrawal headache
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
100.0%
1/1 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
100.0%
1/1 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
50.0%
3/6 • Number of events 3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
50.0%
3/6 • Number of events 4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
50.0%
3/6 • Number of events 3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
66.7%
2/3 • Number of events 2 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.3%
1/3 • Number of events 2 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Restless legs syndrome
|
8.3%
1/12 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Hypomenorrhoea
|
0.00%
0/11 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Menstrual discomfort
|
0.00%
0/11 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.3%
1/3 • Number of events 2 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
100.0%
1/1 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/12 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 32 Days
All participants who received at least one dose of study drug. Gender specific events only occurring 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