Trial Outcomes & Findings for A Study of LY3451838 in Healthy Participants (NCT NCT03692949)
NCT ID: NCT03692949
Last Updated: 2025-09-11
Results Overview
A summary of other non-serious Adverse Events (AE's), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
53 participants
Primary outcome timeframe
Baseline through 20 Weeks
Results posted on
2025-09-11
Participant Flow
Participant milestones
| Measure |
25 Milligram (mg) LY3451838 Part A
25 mg LY3451838 single dose administered intravenously (IV)
|
75 mg LY3451838 Part A
75 mg LY3451838 single dose administered IV.
|
250 mg LY3451838 Part A
250 mg LY3451838 single dose administered IV.
|
500 mg LY3451838 Part A
500 mg LY3451838 single dose administered IV.
|
1000 mg LY3451838 Part A
1000 mg LY3451838 single dose administered IV.
|
1500 mg LY3451838 Part A
1500 mg LY3451838 single dose administered IV.
|
250 mg LY3451838 Part B
250 mg LY3451838 single dose administered subcutaneously (SC).
|
Placebo
Placebo matching single dose administered IV in Part A and administered SC in Part B.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
5
|
6
|
5
|
6
|
6
|
14
|
|
Overall Study
Received at Least One Dose of Study Drug
|
5
|
6
|
5
|
6
|
5
|
6
|
6
|
14
|
|
Overall Study
COMPLETED
|
5
|
6
|
5
|
6
|
5
|
6
|
6
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
25 Milligram (mg) LY3451838 Part A
25 mg LY3451838 single dose administered intravenously (IV)
|
75 mg LY3451838 Part A
75 mg LY3451838 single dose administered IV.
|
250 mg LY3451838 Part A
250 mg LY3451838 single dose administered IV.
|
500 mg LY3451838 Part A
500 mg LY3451838 single dose administered IV.
|
1000 mg LY3451838 Part A
1000 mg LY3451838 single dose administered IV.
|
1500 mg LY3451838 Part A
1500 mg LY3451838 single dose administered IV.
|
250 mg LY3451838 Part B
250 mg LY3451838 single dose administered subcutaneously (SC).
|
Placebo
Placebo matching single dose administered IV in Part A and administered SC in Part B.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of LY3451838 in Healthy Participants
Baseline characteristics by cohort
| Measure |
25 Milligram (mg) LY3451838 Part A
n=5 Participants
25 mg LY3451838 single dose administered intravenously (IV)
|
75 mg LY3451838 Part A
n=6 Participants
75 mg LY3451838 single dose administered IV.
|
250 mg LY3451838 Part A
n=5 Participants
250 mg LY3451838 single dose administered IV.
|
500 mg LY3451838 Part A
n=6 Participants
500 mg LY3451838 single dose administered IV.
|
1000 mg LY3451838 Part A
n=5 Participants
1000 mg LY3451838 single dose administered IV.
|
1500 mg LY3451838 Part A
n=6 Participants
1500 mg LY3451838 single dose administered IV.
|
250 mg LY3451838 Part B
n=6 Participants
250 mg LY3451838 single dose administered subcutaneously (SC).
|
Placebo
n=14 Participants
Placebo matching single dose administered IV in Part A and administered SC in Part B.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
47.6 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
44.0 years
STANDARD_DEVIATION 14.3 • n=7 Participants
|
41.4 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
40.2 years
STANDARD_DEVIATION 15.0 • n=4 Participants
|
38.4 years
STANDARD_DEVIATION 9.6 • n=21 Participants
|
43.3 years
STANDARD_DEVIATION 11.3 • n=10 Participants
|
49.8 years
STANDARD_DEVIATION 6.0 • n=115 Participants
|
40.5 years
STANDARD_DEVIATION 11.0 • n=24 Participants
|
42.8 years
STANDARD_DEVIATION 11.4 • n=42 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
12 Participants
n=24 Participants
|
45 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
14 Participants
n=24 Participants
|
52 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
14 Participants
n=24 Participants
|
53 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
Singapore
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
14 Participants
n=24 Participants
|
53 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline through 20 WeeksPopulation: All participants who received at least one dose of study drug.
A summary of other non-serious Adverse Events (AE's), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.
Outcome measures
| Measure |
25 Milligram (mg) LY3451838 Part A
n=5 Participants
25 mg LY3451838 single dose administered intravenously (IV)
|
75 mg LY3451838 Part A
n=6 Participants
75 mg LY3451838 single dose administered IV.
|
250 mg LY3451838 Part A
n=5 Participants
250 mg LY3451838 single dose administered IV.
|
500 mg LY3451838 Part A
n=6 Participants
500 mg LY3451838 single dose administered IV.
|
1000 mg LY3451838 Part A
n=5 Participants
1000 mg LY3451838 single dose administered IV.
|
1500 mg LY3451838 Part A
n=6 Participants
1500 mg LY3451838 single dose administered IV.
|
250 mg LY3451838 Part B
n=6 Participants
250 mg LY3451838 single dose administered subcutaneously (SC).
|
Placebo
n=14 Participants
Placebo matching single dose administered IV in Part A and administered SC in Part B.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Any Treatment Emergent Adverse Event
|
4 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: Baseline through 20 WeeksPopulation: All participants who received at least one dose of study drug.
A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Outcome measures
| Measure |
25 Milligram (mg) LY3451838 Part A
n=5 Participants
25 mg LY3451838 single dose administered intravenously (IV)
|
75 mg LY3451838 Part A
n=6 Participants
75 mg LY3451838 single dose administered IV.
|
250 mg LY3451838 Part A
n=5 Participants
250 mg LY3451838 single dose administered IV.
|
500 mg LY3451838 Part A
n=6 Participants
500 mg LY3451838 single dose administered IV.
|
1000 mg LY3451838 Part A
n=5 Participants
1000 mg LY3451838 single dose administered IV.
|
1500 mg LY3451838 Part A
n=6 Participants
1500 mg LY3451838 single dose administered IV.
|
250 mg LY3451838 Part B
n=6 Participants
250 mg LY3451838 single dose administered subcutaneously (SC).
|
Placebo
n=14 Participants
Placebo matching single dose administered IV in Part A and administered SC in Part B.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Part A: Predose, End of Infusion, 3, 6, 12, 24, 36, 48 h, and Days 5, 7, 9, 15, 22, 29, 43, 57, 71, 85, and 141 post-dose; Part B: Predose, 3, 6, 12, 24, 36, 48 h, and Days 5, 7, 9, 15, 22, 29, 43, 57, 71, 85, and 141 post-dosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
PK: AUC of LY3451838
Outcome measures
| Measure |
25 Milligram (mg) LY3451838 Part A
n=4 Participants
25 mg LY3451838 single dose administered intravenously (IV)
|
75 mg LY3451838 Part A
n=6 Participants
75 mg LY3451838 single dose administered IV.
|
250 mg LY3451838 Part A
n=5 Participants
250 mg LY3451838 single dose administered IV.
|
500 mg LY3451838 Part A
n=6 Participants
500 mg LY3451838 single dose administered IV.
|
1000 mg LY3451838 Part A
n=5 Participants
1000 mg LY3451838 single dose administered IV.
|
1500 mg LY3451838 Part A
n=6 Participants
1500 mg LY3451838 single dose administered IV.
|
250 mg LY3451838 Part B
n=4 Participants
250 mg LY3451838 single dose administered subcutaneously (SC).
|
Placebo
Placebo matching single dose administered IV in Part A and administered SC in Part B.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Serum Concentration-Time Curve From 0 to Infinity (AUC 0 -∞) of LY3451838
|
1580 microgram*hour per milliliter (μg*h/mL)
Geometric Coefficient of Variation 25.0
|
7510 microgram*hour per milliliter (μg*h/mL)
Geometric Coefficient of Variation 24.4
|
21900 microgram*hour per milliliter (μg*h/mL)
Geometric Coefficient of Variation 25.0
|
46100 microgram*hour per milliliter (μg*h/mL)
Geometric Coefficient of Variation 15.4
|
85500 microgram*hour per milliliter (μg*h/mL)
Geometric Coefficient of Variation 19.6
|
128000 microgram*hour per milliliter (μg*h/mL)
Geometric Coefficient of Variation 12.2
|
2040 microgram*hour per milliliter (μg*h/mL)
Geometric Coefficient of Variation 57.0
|
—
|
SECONDARY outcome
Timeframe: Part A: Predose, End of Infusion, 3, 6, 12, 24, 36, 48 h, and Days 5, 7, 9, 15, 22, 29, 43, 57, 71, 85, and 141 post-dose; Part B: Predose, 3, 6, 12, 24, 36, 48 h, and Days 5, 7, 9, 15, 22, 29, 43, 57, 71, 85, and 141 post-dosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
PK: Cmax of LY3451838
Outcome measures
| Measure |
25 Milligram (mg) LY3451838 Part A
n=4 Participants
25 mg LY3451838 single dose administered intravenously (IV)
|
75 mg LY3451838 Part A
n=6 Participants
75 mg LY3451838 single dose administered IV.
|
250 mg LY3451838 Part A
n=5 Participants
250 mg LY3451838 single dose administered IV.
|
500 mg LY3451838 Part A
n=6 Participants
500 mg LY3451838 single dose administered IV.
|
1000 mg LY3451838 Part A
n=5 Participants
1000 mg LY3451838 single dose administered IV.
|
1500 mg LY3451838 Part A
n=6 Participants
1500 mg LY3451838 single dose administered IV.
|
250 mg LY3451838 Part B
n=6 Participants
250 mg LY3451838 single dose administered subcutaneously (SC).
|
Placebo
Placebo matching single dose administered IV in Part A and administered SC in Part B.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY3451838
|
8.54 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 39.1
|
30.9 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 13.4
|
89.1 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 15.8
|
172 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 27.1
|
318 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 24.1
|
523 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 22.4
|
1.97 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 113.7
|
—
|
Adverse Events
25 mg LY3451838 Part A
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
75 mg LY3451838 Part A
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
250 mg LY3451838 Part A
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
500 mg LY3451838 Part A
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
1000 mg LY3451838 Part A
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
1500 mg LY3451838 Part A
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
250 mg LY3451838 Part B
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
25 mg LY3451838 Part A
n=5 participants at risk
25 milligrams (mg) LY3451838 single dose administered Intravenously (IV).
|
75 mg LY3451838 Part A
n=6 participants at risk
75 mg LY3451838 single dose administered IV.
|
250 mg LY3451838 Part A
n=5 participants at risk
250 mg LY3451838 single dose administered IV.
|
500 mg LY3451838 Part A
n=6 participants at risk
500 mg LY3451838 single dose administered IV.
|
1000 mg LY3451838 Part A
n=5 participants at risk
1000 mg LY3451838 single dose administered IV.
|
1500 mg LY3451838 Part A
n=6 participants at risk
1500 mg LY3451838 single dose administered IV.
|
250 mg LY3451838 Part B
n=6 participants at risk
250 mg LY3451838 or Placebo administered subcutaneously (SC).
|
Placebo
n=14 participants at risk
Placebo administered IV in Part A and administered SC in Part B.
|
|---|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 2 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 3 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 4 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Application site erythema
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Catheter site bruise
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
14.3%
2/14 • Number of events 2 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Catheter site pain
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Catheter site paraesthesia
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Catheter site swelling
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Infusion site bruising
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Infusion site pain
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Infusion site swelling
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Malaise
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Peripheral swelling
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 3 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Vessel puncture site bruise
|
40.0%
2/5 • Number of events 3 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
50.0%
3/6 • Number of events 4 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
40.0%
2/5 • Number of events 2 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
28.6%
4/14 • Number of events 5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Vessel puncture site erythema
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Vessel puncture site swelling
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Immune system disorders
Allergy to arthropod bite
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
14.3%
2/14 • Number of events 2 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Viral infection
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
14.3%
2/14 • Number of events 2 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
40.0%
2/5 • Number of events 2 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 3 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
40.0%
2/5 • Number of events 3 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 3 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
14.3%
2/14 • Number of events 4 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
21.4%
3/14 • Number of events 3 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 3 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 3 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
14.3%
2/14 • Number of events 2 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 4 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 3 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
14.3%
2/14 • Number of events 3 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
40.0%
2/5 • Number of events 2 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
14.3%
2/14 • Number of events 2 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
40.0%
2/5 • Number of events 2 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 3 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 4 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 3 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline up to 20 Weeks
All participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place