Trial Outcomes & Findings for A Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis (NCT NCT03443024)
NCT ID: NCT03443024
Last Updated: 2021-05-04
Results Overview
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). Least Square (LS) Means were calculated using analysis of covariance (ANCOVA) with the factor of treatment and the baseline EASI as covariate. Note: Missing values were imputed using Markov Chain Monte Carlo (MCMC) multiple imputation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
280 participants
Primary outcome timeframe
Baseline, Week 16
Results posted on
2021-05-04
Participant Flow
Participant milestones
| Measure |
125 Milligrams (mg) Lebrikizumab - Every 4 Weeks (Q4W)
125 milligrams (mg) Lebrikizumab administered subcutaneously (SC) once every Q4W.
Baseline: Loading dose 250 mg Lebrikizumab SC (two injections SC 1-mL of 125 mg/mL Lebrikizumab and 1-mL placebo).
Week 2: Four 1-mL SC injections placebo.
Weeks 4, 8, 12: 125 mg SC Lebrikizumab and 1-mL SC placebo.
Weeks 6, 10, 14: Two 1-mL SC placebo.
|
250 mg Lebrikizumab (Q4W)
250 mg Lebrikizumab administered SC once every 4 weeks.
Baseline: Loading dose of 500 mg (four 1-mL SC injections of 125 mg/mL Lebrikizumab).
Week 2: Four 1-mL SC injections of placebo.
Weeks 4, 8, 12: 250 mg (two 1-mL injections of 125 mg/mL Lebrikizumab).
Weeks 6, 10, 14: Two 1-mL injections of placebo.
|
250 mg Lebrikizumab - Every 2 Weeks (Q2W)
250 mg Lebrikizumab administered SC once every 2 weeks.
Baseline and Week 2: Loading dose of 500 mg (four 1-mL SC injections of 125 mg/mL Lebrikizumab).
Week 4, 6, 8, 10, 12, 14: 250 mg (two 1-mL SC injections of 125 mg/mL Lebrikizumab).
|
Placebo
Placebo administered SC once every 2 weeks.
Baseline and Week 2: Four 1-mL SC injections of placebo.
Week 4, 6, 8, 10, 12, 14: Two 1-mL SC injections of placebo.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
73
|
80
|
75
|
52
|
|
Overall Study
Received at Least One Dose of Study Drug
|
73
|
80
|
75
|
52
|
|
Overall Study
COMPLETED
|
52
|
49
|
56
|
20
|
|
Overall Study
NOT COMPLETED
|
21
|
31
|
19
|
32
|
Reasons for withdrawal
| Measure |
125 Milligrams (mg) Lebrikizumab - Every 4 Weeks (Q4W)
125 milligrams (mg) Lebrikizumab administered subcutaneously (SC) once every Q4W.
Baseline: Loading dose 250 mg Lebrikizumab SC (two injections SC 1-mL of 125 mg/mL Lebrikizumab and 1-mL placebo).
Week 2: Four 1-mL SC injections placebo.
Weeks 4, 8, 12: 125 mg SC Lebrikizumab and 1-mL SC placebo.
Weeks 6, 10, 14: Two 1-mL SC placebo.
|
250 mg Lebrikizumab (Q4W)
250 mg Lebrikizumab administered SC once every 4 weeks.
Baseline: Loading dose of 500 mg (four 1-mL SC injections of 125 mg/mL Lebrikizumab).
Week 2: Four 1-mL SC injections of placebo.
Weeks 4, 8, 12: 250 mg (two 1-mL injections of 125 mg/mL Lebrikizumab).
Weeks 6, 10, 14: Two 1-mL injections of placebo.
|
250 mg Lebrikizumab - Every 2 Weeks (Q2W)
250 mg Lebrikizumab administered SC once every 2 weeks.
Baseline and Week 2: Loading dose of 500 mg (four 1-mL SC injections of 125 mg/mL Lebrikizumab).
Week 4, 6, 8, 10, 12, 14: 250 mg (two 1-mL SC injections of 125 mg/mL Lebrikizumab).
|
Placebo
Placebo administered SC once every 2 weeks.
Baseline and Week 2: Four 1-mL SC injections of placebo.
Week 4, 6, 8, 10, 12, 14: Two 1-mL SC injections of placebo.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
4
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
9
|
9
|
7
|
5
|
|
Overall Study
Withdrawal by Subject
|
8
|
15
|
9
|
23
|
|
Overall Study
Physician Decision
|
1
|
2
|
0
|
1
|
|
Overall Study
Sponsor Decision
|
1
|
1
|
0
|
0
|
|
Overall Study
Protocol Deviation
|
0
|
0
|
0
|
2
|
Baseline Characteristics
A Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
125 mg Lebrikizumab (Q4W)
n=73 Participants
125 mg Lebrikizumab administered SC once every 4 weeks.
|
250 mg Lebrikizumab (Q4W)
n=80 Participants
250 mg Lebrikizumab administered SC once every 4 weeks.
|
250 mg Lebrikizumab (Q2W)
n=75 Participants
250 mg Lebrikizumab administered SC once every 2 weeks.
|
Placebo
n=52 Participants
Placebo administered SC once every 2 weeks.
|
Total
n=280 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36.7 years
STANDARD_DEVIATION 16.54 • n=93 Participants
|
40.2 years
STANDARD_DEVIATION 17.88 • n=4 Participants
|
38.9 years
STANDARD_DEVIATION 17.36 • n=27 Participants
|
42.2 years
STANDARD_DEVIATION 18.21 • n=483 Participants
|
39.3 years
STANDARD_DEVIATION 17.48 • n=36 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=93 Participants
|
47 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
166 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
28 Participants
n=483 Participants
|
114 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
42 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=93 Participants
|
69 Participants
n=4 Participants
|
63 Participants
n=27 Participants
|
47 Participants
n=483 Participants
|
238 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
27 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
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
93 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
26 Participants
n=483 Participants
|
145 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
12 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
|
|
Region of Enrollment
United States
|
73 Participants
n=93 Participants
|
80 Participants
n=4 Participants
|
75 Participants
n=27 Participants
|
52 Participants
n=483 Participants
|
280 Participants
n=36 Participants
|
|
Eczema Area and Severity Index (EASI)
|
29.85 units on a scale
STANDARD_DEVIATION 13.517 • n=93 Participants
|
26.15 units on a scale
STANDARD_DEVIATION 10.135 • n=4 Participants
|
25.48 units on a scale
STANDARD_DEVIATION 11.206 • n=27 Participants
|
28.90 units on a scale
STANDARD_DEVIATION 11.790 • n=483 Participants
|
27.45 units on a scale
STANDARD_DEVIATION 11.764 • n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants who received at least one dose of study drug and had Week 16 EASI data.
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). Least Square (LS) Means were calculated using analysis of covariance (ANCOVA) with the factor of treatment and the baseline EASI as covariate. Note: Missing values were imputed using Markov Chain Monte Carlo (MCMC) multiple imputation.
Outcome measures
| Measure |
125 mg Lebrikizumab (Q4W)
n=73 Participants
125 mg Lebrikizumab administered SC once Q4W.
|
250 mg Lebrikizumab (Q4W)
n=80 Participants
250 mg Lebrikizumab administered SC once Q4W.
|
250 mg Lebrikizumab (Q2W)
n=75 Participants
250 mg Lebrikizumab administered SC once Q2W.
|
Placebo
n=52 Participants
Placebo administered SC once Q2W.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Eczema Area and Severity Index (EASI)
|
-62.34 percent change
Standard Deviation 37.266
|
-69.21 percent change
Standard Deviation 38.282
|
-72.09 percent change
Standard Deviation 37.229
|
-41.12 percent change
Standard Deviation 59.496
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants who received at least one dose of study drug.
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score.
Outcome measures
| Measure |
125 mg Lebrikizumab (Q4W)
n=73 Participants
125 mg Lebrikizumab administered SC once Q4W.
|
250 mg Lebrikizumab (Q4W)
n=80 Participants
250 mg Lebrikizumab administered SC once Q4W.
|
250 mg Lebrikizumab (Q2W)
n=75 Participants
250 mg Lebrikizumab administered SC once Q2W.
|
Placebo
n=52 Participants
Placebo administered SC once Q2W.
|
|---|---|---|---|---|
|
Percentage of Participants With a 75% Improvement From Baseline in EASI (EASI75) at Week 16
|
43.3 percentage of participants
|
56.1 percentage of participants
|
60.6 percentage of participants
|
24.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants who received at least one dose of study drug.
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Outcome measures
| Measure |
125 mg Lebrikizumab (Q4W)
n=73 Participants
125 mg Lebrikizumab administered SC once Q4W.
|
250 mg Lebrikizumab (Q4W)
n=80 Participants
250 mg Lebrikizumab administered SC once Q4W.
|
250 mg Lebrikizumab (Q2W)
n=75 Participants
250 mg Lebrikizumab administered SC once Q2W.
|
Placebo
n=52 Participants
Placebo administered SC once Q2W.
|
|---|---|---|---|---|
|
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) and a Reduction ≥2 Points From Baseline to Week 16 (5-point Scale)
|
26.6 percentage of participants
|
33.7 percentage of participants
|
44.6 percentage of participants
|
15.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants who received at least one dose of study drug.
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).
Outcome measures
| Measure |
125 mg Lebrikizumab (Q4W)
n=73 Participants
125 mg Lebrikizumab administered SC once Q4W.
|
250 mg Lebrikizumab (Q4W)
n=80 Participants
250 mg Lebrikizumab administered SC once Q4W.
|
250 mg Lebrikizumab (Q2W)
n=75 Participants
250 mg Lebrikizumab administered SC once Q2W.
|
Placebo
n=52 Participants
Placebo administered SC once Q2W.
|
|---|---|---|---|---|
|
Percentage of Participants With EASI <7 at Week 16
|
42.2 percentage of participants
|
61.2 percentage of participants
|
61.8 percentage of participants
|
29.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants who received at least one dose of study drug.
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 50% improvement from baseline in the EASI score.
Outcome measures
| Measure |
125 mg Lebrikizumab (Q4W)
n=73 Participants
125 mg Lebrikizumab administered SC once Q4W.
|
250 mg Lebrikizumab (Q4W)
n=80 Participants
250 mg Lebrikizumab administered SC once Q4W.
|
250 mg Lebrikizumab (Q2W)
n=75 Participants
250 mg Lebrikizumab administered SC once Q2W.
|
Placebo
n=52 Participants
Placebo administered SC once Q2W.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving EASI50 at Week 16
|
66.4 percentage of participants
|
77.0 percentage of participants
|
81.0 percentage of participants
|
45.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants who received at least one dose of study drug.
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score
Outcome measures
| Measure |
125 mg Lebrikizumab (Q4W)
n=73 Participants
125 mg Lebrikizumab administered SC once Q4W.
|
250 mg Lebrikizumab (Q4W)
n=80 Participants
250 mg Lebrikizumab administered SC once Q4W.
|
250 mg Lebrikizumab (Q2W)
n=75 Participants
250 mg Lebrikizumab administered SC once Q2W.
|
Placebo
n=52 Participants
Placebo administered SC once Q2W.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving EASI90 at Week 16
|
26.1 percentage of participants
|
36.1 percentage of participants
|
44.0 percentage of participants
|
11.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants who received at least one dose of study drug and had Week 16 Sleep Loss Scale score.
The Sleep Loss Scale is used by the participants to report the impact of itching on their sleep every night. Participants responded to the question to what extent did your itching interfere with your sleep last night. The scale ranged from 0 to 4, with 0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments were recorded daily by the participant using an electronic diary. Least Squares (LS) Means were calculated using ANCOVA with the factor of treatment and the baseline sleep-loss scale as covariates.
Outcome measures
| Measure |
125 mg Lebrikizumab (Q4W)
n=38 Participants
125 mg Lebrikizumab administered SC once Q4W.
|
250 mg Lebrikizumab (Q4W)
n=33 Participants
250 mg Lebrikizumab administered SC once Q4W.
|
250 mg Lebrikizumab (Q2W)
n=38 Participants
250 mg Lebrikizumab administered SC once Q2W.
|
Placebo
n=14 Participants
Placebo administered SC once Q2W.
|
|---|---|---|---|---|
|
Percent Change From Baseline in the Sleep Loss Scale Score
|
-48.68 percent change
Standard Deviation 50.692
|
-53.03 percent change
Standard Deviation 50.662
|
-64.69 percent change
Standard Deviation 50.692
|
-20.24 percent change
Standard Deviation 51.066
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants who received least one dose of study drug and had Week 16 Pruritus NRS score.
The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. Pruritus assessments were recorded daily by the participant using an electronic diary. LS Means were calculated using ANCOVA with the factor of treatments and the baseline pruritus NRS as covariates.
Outcome measures
| Measure |
125 mg Lebrikizumab (Q4W)
n=55 Participants
125 mg Lebrikizumab administered SC once Q4W.
|
250 mg Lebrikizumab (Q4W)
n=56 Participants
250 mg Lebrikizumab administered SC once Q4W.
|
250 mg Lebrikizumab (Q2W)
n=50 Participants
250 mg Lebrikizumab administered SC once Q2W.
|
Placebo
n=22 Participants
Placebo administered SC once Q2W.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Pruritus Numeric Rating Score (NRS)
|
-35.94 percent change
Standard Deviation 55.553
|
-49.60 percent change
Standard Deviation 55.555
|
-60.63 percent change
Standard Deviation 55.564
|
4.26 percent change
Standard Deviation 55.610
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants who received at least one dose of study drug and had a \>=3 point improvement from Baseline in Week 16 Pruritus NRS score.
The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. Assessments were recorded daily by the participant using an electronic diary. The percentage of participants who are dichotomized to success (pruritus NRS greater than or equal to 3-point improvement) at Week 16 will be analyzed using a Cochran-Mantel-Haenszel (CMH) test.
Outcome measures
| Measure |
125 mg Lebrikizumab (Q4W)
n=55 Participants
125 mg Lebrikizumab administered SC once Q4W.
|
250 mg Lebrikizumab (Q4W)
n=57 Participants
250 mg Lebrikizumab administered SC once Q4W.
|
250 mg Lebrikizumab (Q2W)
n=50 Participants
250 mg Lebrikizumab administered SC once Q2W.
|
Placebo
n=22 Participants
Placebo administered SC once Q2W.
|
|---|---|---|---|---|
|
Percentage of Participants With Pruritus NRS Change of ≥3 at Week 16
|
50.9 percentage of participants
|
64.9 percentage of participants
|
76.0 percentage of participants
|
45.5 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants who received at least one dose of study drug and had a \>=4 point improvement from Baseline in Week 16 Pruritus NRS score.
The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. Assessments were recorded daily by the participant using an electronic diary. The percentage of participants who are dichotomized to success (pruritus NRS greater than or equal to 4-point improvement) at Week 16 will be analyzed using a Cochran-Mantel-Haenszel (CMH) test.
Outcome measures
| Measure |
125 mg Lebrikizumab (Q4W)
n=55 Participants
125 mg Lebrikizumab administered SC once Q4W.
|
250 mg Lebrikizumab (Q4W)
n=57 Participants
250 mg Lebrikizumab administered SC once Q4W.
|
250 mg Lebrikizumab (Q2W)
n=50 Participants
250 mg Lebrikizumab administered SC once Q2W.
|
Placebo
n=22 Participants
Placebo administered SC once Q2W.
|
|---|---|---|---|---|
|
Percentage of Participants With Pruritus NRS Change of ≥4 From Baseline to Week 16
|
41.8 percentage of participants
|
47.4 percentage of participants
|
70.0 percentage of participants
|
27.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants who received at least one dose of study drug and had Week 16 BSA data.
The body surface area (BSA) affected by AD will be assessed for 4 separate body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). Percent of BSA for a body region was calculated as = total number of palms in a body region \* % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of AD.
Outcome measures
| Measure |
125 mg Lebrikizumab (Q4W)
n=59 Participants
125 mg Lebrikizumab administered SC once Q4W.
|
250 mg Lebrikizumab (Q4W)
n=62 Participants
250 mg Lebrikizumab administered SC once Q4W.
|
250 mg Lebrikizumab (Q2W)
n=59 Participants
250 mg Lebrikizumab administered SC once Q2W.
|
Placebo
n=24 Participants
Placebo administered SC once Q2W.
|
|---|---|---|---|---|
|
Change From Baseline in Body Surface Area (BSA) Involved With Atopic Dermatitis (AD)
|
-19.6 percentage of BSA
Standard Deviation 19.08
|
-24.9 percentage of BSA
Standard Deviation 20.08
|
-24.3 percentage of BSA
Standard Deviation 21.00
|
-17.4 percentage of BSA
Standard Deviation 20.56
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants who received at least one dose of study drug and had evaluable Week 16 ADIQ data.
The ADIQ is a 17-item questionnaire used to assess the participant's AD-specific health-related quality of life. Each item is rated on a 5-point scale from 0 to 4, with higher numbers indicating greater burden. The questionnaire assesses AD's impact on emotions, energy, activities of daily living, and social activities. The ADIQ has a recall specification of 7 days. Assessments were recorded by the participant using an electronic diary and transferred to the clinical database.The ADIQ score is calculated by summing the score of each of the 14 questions resulting in a maximum of 56 and a minimum of 0, with higher scores indicating greater burden.
Outcome measures
| Measure |
125 mg Lebrikizumab (Q4W)
n=38 Participants
125 mg Lebrikizumab administered SC once Q4W.
|
250 mg Lebrikizumab (Q4W)
n=33 Participants
250 mg Lebrikizumab administered SC once Q4W.
|
250 mg Lebrikizumab (Q2W)
n=35 Participants
250 mg Lebrikizumab administered SC once Q2W.
|
Placebo
n=17 Participants
Placebo administered SC once Q2W.
|
|---|---|---|---|---|
|
Change From Baseline in Atopic Dermatitis Impact Questionnaire (ADIQ) Score
|
-14.2 score on a scale
Standard Deviation 12.74
|
-18.8 score on a scale
Standard Deviation 12.03
|
-18.6 score on a scale
Standard Deviation 12.63
|
-11.0 score on a scale
Standard Deviation 13.96
|
Adverse Events
125 mg Lebrikizumab (Q4W)
Serious events: 2 serious events
Other events: 41 other events
Deaths: 0 deaths
250 mg Lebrikizumab (Q4W)
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
250 mg Lebrikizumab (Q2W)
Serious events: 2 serious events
Other events: 45 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
125 mg Lebrikizumab (Q4W)
n=73 participants at risk
125 mg Lebrikizumab administered SC once Q4W.
|
250 mg Lebrikizumab (Q4W)
n=80 participants at risk
250 mg Lebrikizumab administered SC once Q4W.
|
250 mg Lebrikizumab (Q2W)
n=75 participants at risk
250 mg Lebrikizumab administered SC once Q2W.
|
Placebo
n=52 participants at risk
Placebo administered SC once Q2W.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Hernial eventration
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Chest pain
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Oedema peripheral
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Other adverse events
| Measure |
125 mg Lebrikizumab (Q4W)
n=73 participants at risk
125 mg Lebrikizumab administered SC once Q4W.
|
250 mg Lebrikizumab (Q4W)
n=80 participants at risk
250 mg Lebrikizumab administered SC once Q4W.
|
250 mg Lebrikizumab (Q2W)
n=75 participants at risk
250 mg Lebrikizumab administered SC once Q2W.
|
Placebo
n=52 participants at risk
Placebo administered SC once Q2W.
|
|---|---|---|---|---|
|
Infections and infestations
Herpes simplex
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.5%
2/80 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Impetigo
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Influenza
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Injection site infection
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Fungal skin infection
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis viral
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Genital herpes
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Tachycardia
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Endocrine disorders
Goitre
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Chalazion
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Dry eye
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
2/52 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Eye irritation
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Glaucoma
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.7%
2/73 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.7%
2/75 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
3/80 • Number of events 3 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.7%
2/75 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.5%
2/80 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Application site rash
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Chest pain
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Cyst
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Cyst rupture
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Face oedema
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Fatigue
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
4/80 • Number of events 4 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site dermatitis
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site erythema
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.5%
2/80 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.0%
3/75 • Number of events 6 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site oedema
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site pain
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
3/80 • Number of events 8 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
4/75 • Number of events 20 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site pruritus
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site rash
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site reaction
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site swelling
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Malaise
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Mass
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Oedema peripheral
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.5%
2/80 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pain
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Peripheral swelling
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.7%
2/75 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Alveolar osteitis
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Bacterial vaginosis
|
4.3%
2/46 • Number of events 3 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/49 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Bacterial vulvovaginitis
|
0.00%
0/46 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
1/47 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/49 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Body tinea
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
2/52 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Conjunctivitis
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.7%
2/75 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Ear infection
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Eczema herpeticum
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
5.5%
4/73 • Number of events 5 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.5%
2/80 • Number of events 3 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
12.0%
9/75 • Number of events 11 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
2/52 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Oral herpes
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.5%
2/80 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Otitis media
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.5%
2/80 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.7%
2/75 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 4 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Respiratory tract infection viral
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.5%
2/80 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Skin infection
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Tonsillitis
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.2%
6/73 • Number of events 7 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
11.2%
9/80 • Number of events 10 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.7%
2/75 • Number of events 3 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.8%
3/52 • Number of events 3 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
2.7%
2/73 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Viral tonsillitis
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.4%
1/73 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
2.2%
1/46 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/49 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/46 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
1/47 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
1/49 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Vulvovaginitis gonococcal
|
0.00%
0/46 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/49 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Sunburn
|
1.4%
1/73 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Alanine aminotransferase increased
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.5%
2/80 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.7%
2/75 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.7%
2/75 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Bilirubin conjugated increased
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood bilirubin increased
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood lactate dehydrogenase increased
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood potassium increased
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood pressure increased
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Cardiac murmur
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Haematocrit increased
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Haemoglobin increased
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Protein urine present
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Urine leukocyte esterase positive
|
2.7%
2/73 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Weight increased
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.7%
2/73 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.5%
2/80 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
2/52 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.1%
3/73 • Number of events 3 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.5%
2/80 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.7%
2/75 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Auditory nerve disorder
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
4.1%
3/73 • Number of events 3 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
4/75 • Number of events 4 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.8%
3/52 • Number of events 4 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Migraine
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Paraesthesia
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.5%
2/80 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Syncope
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Pregnancy, puerperium and perinatal conditions
Vomiting in pregnancy
|
0.00%
0/46 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/49 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Anxiety
|
4.1%
3/73 • Number of events 3 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.7%
2/75 • Number of events 3 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Depression
|
1.4%
1/73 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Bilirubinuria
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/46 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
1/49 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/46 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
1/49 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.4%
1/73 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.7%
2/73 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.7%
2/75 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.7%
2/73 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.7%
2/75 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
2.7%
2/73 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.5%
2/80 • Number of events 3 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.8%
3/52 • Number of events 3 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.0%
3/75 • Number of events 3 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Hypersensitivity vasculitis
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Milia
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.4%
1/73 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.7%
2/75 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.5%
2/80 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin fragility
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/80 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
2.7%
2/73 • Number of events 2 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
1/75 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/73 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to 271 days
All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60