Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis (NCT NCT05061693)
NCT ID: NCT05061693
Last Updated: 2025-07-11
Results Overview
Each evening, the participants assessed their worst level of itch during the past 24 hours on a scale of 0 (no itch) to 10 (worst itch imaginable). The Baseline Itch NRS score was determined by averaging the 7 daily Itch NRS scores before Day 1 (i.e., Day -7 to Day -1). If ≥4 of the 7 days of the daily Itch NRS scores were missing prior to Day 1, then the Baseline Itch NRS score was set to "missing." The by-visit Itch NRS score for postbaseline visits was determined by averaging the 7 daily Itch NRS scores before the visit day. If 4 or more daily Itch NRS scores out of the 7 days before the visit day were missing, the Itch NRS score at the visit was set to missing.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
146 participants
Primary outcome timeframe
Baseline; Week 16
Results posted on
2025-07-11
Participant Flow
The study was conducted across 40 sites in Canada, Germany, Spain, Poland, Puerto Rico, and the United States.
Participant milestones
| Measure |
PC Period: Placebo
On Day 1, participants were randomized to receive matching placebo once daily (QD) and stratified by Investigator's Global Assessment (IGA) score (3 versus 4). Participants received blinded study drug through Week 16.
|
PC Period: Povorcitinib 15 mg
On Day 1, participants were randomized to receive povorcitinib 15 milligrams (mg) QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
PC Period: Povorcitinib 45 mg
On Day 1, participants were randomized to receive povorcitinib 45 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
PC Period: Povorcitinib 75 mg
On Day 1, participants were randomized to receive povorcitinib 75 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Extension Period: Placebo to Povorcitinib 45 mg
Participants who received placebo during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch Numerical Rating Scale (NRS) score and Investigator's Global Assessment-Treatment Success (IGA-TS) who did not receive rescue therapy during the placebo-controlled period.
|
Extension Period: Povorcitinib 15 mg to 45 mg
Participants who received povorcitinib 15 mg during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch NRS score and IGA-TS who did not receive rescue therapy during the placebo-controlled period.
|
Extension Period: Povorcitinib 45 mg to 45 mg
Participants who received povorcitinib 45 mg during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for an additional 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch NRS score and IGA-TS who did not receive rescue therapy during the placebo-controlled period.
|
Extension Period: Povorcitinib 75 mg to 45 mg
Participants who received povorcitinib 75 mg during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch NRS score and IGA-TS who did not receive rescue therapy during the placebo-controlled period.
|
Extension Period: Placebo to Povorcitinib 75 mg
Participants who received placebo during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Extension Period: Povorcitinib 15 mg to 75 mg
Participants who received povorcitinib 15 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Extension Period: Povorcitinib 45 mg to 75 mg
Participants who received povorcitinib 45 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Extension Period: Povorcitinib 75 mg to 75 mg
Participants who received povorcitinib 75 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for an additional 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
16-week Placebo-controlled (PC) Period
STARTED
|
37
|
36
|
36
|
37
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
16-week Placebo-controlled (PC) Period
COMPLETED
|
32
|
29
|
31
|
33
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
16-week Placebo-controlled (PC) Period
NOT COMPLETED
|
5
|
7
|
5
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
24-week Extension Period
STARTED
|
0
|
0
|
0
|
0
|
1
|
4
|
8
|
15
|
30
|
25
|
23
|
18
|
|
24-week Extension Period
COMPLETED
|
0
|
0
|
0
|
0
|
1
|
4
|
7
|
12
|
25
|
22
|
18
|
13
|
|
24-week Extension Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
3
|
5
|
3
|
5
|
5
|
Reasons for withdrawal
| Measure |
PC Period: Placebo
On Day 1, participants were randomized to receive matching placebo once daily (QD) and stratified by Investigator's Global Assessment (IGA) score (3 versus 4). Participants received blinded study drug through Week 16.
|
PC Period: Povorcitinib 15 mg
On Day 1, participants were randomized to receive povorcitinib 15 milligrams (mg) QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
PC Period: Povorcitinib 45 mg
On Day 1, participants were randomized to receive povorcitinib 45 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
PC Period: Povorcitinib 75 mg
On Day 1, participants were randomized to receive povorcitinib 75 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Extension Period: Placebo to Povorcitinib 45 mg
Participants who received placebo during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch Numerical Rating Scale (NRS) score and Investigator's Global Assessment-Treatment Success (IGA-TS) who did not receive rescue therapy during the placebo-controlled period.
|
Extension Period: Povorcitinib 15 mg to 45 mg
Participants who received povorcitinib 15 mg during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch NRS score and IGA-TS who did not receive rescue therapy during the placebo-controlled period.
|
Extension Period: Povorcitinib 45 mg to 45 mg
Participants who received povorcitinib 45 mg during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for an additional 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch NRS score and IGA-TS who did not receive rescue therapy during the placebo-controlled period.
|
Extension Period: Povorcitinib 75 mg to 45 mg
Participants who received povorcitinib 75 mg during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch NRS score and IGA-TS who did not receive rescue therapy during the placebo-controlled period.
|
Extension Period: Placebo to Povorcitinib 75 mg
Participants who received placebo during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Extension Period: Povorcitinib 15 mg to 75 mg
Participants who received povorcitinib 15 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Extension Period: Povorcitinib 45 mg to 75 mg
Participants who received povorcitinib 45 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Extension Period: Povorcitinib 75 mg to 75 mg
Participants who received povorcitinib 75 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for an additional 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
16-week Placebo-controlled (PC) Period
Adverse Event
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
16-week Placebo-controlled (PC) Period
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
16-week Placebo-controlled (PC) Period
Lack of Efficacy
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
16-week Placebo-controlled (PC) Period
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
16-week Placebo-controlled (PC) Period
Protocol Violation
|
1
|
1
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
16-week Placebo-controlled (PC) Period
Withdrawal by Subject
|
2
|
4
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
24-week Extension Period
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
0
|
1
|
3
|
|
24-week Extension Period
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
24-week Extension Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
0
|
0
|
|
24-week Extension Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
2
|
1
|
|
24-week Extension Period
Sponsor Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
24-week Extension Period
Site Closure
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis
Baseline characteristics by cohort
| Measure |
Placebo
n=37 Participants
On Day 1, participants were randomized to receive matching placebo once daily (QD) and stratified by Investigator's Global Assessment (IGA) score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 15 mg
n=36 Participants
On Day 1, participants were randomized to receive povorcitinib 15 milligrams (mg) QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 45 mg
n=36 Participants
On Day 1, participants were randomized to receive povorcitinib 45 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 75 mg
n=37 Participants
On Day 1, participants were randomized to receive povorcitinib 75 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
52.9 years
STANDARD_DEVIATION 12.32 • n=5 Participants
|
56.0 years
STANDARD_DEVIATION 12.92 • n=7 Participants
|
55.6 years
STANDARD_DEVIATION 15.25 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 10.18 • n=4 Participants
|
55.1 years
STANDARD_DEVIATION 12.70 • n=21 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
96 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
128 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
33 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
121 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black/African-American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American-Indian/Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 16Population: Intent-to-Treat (ITT) Population: all randomized participants. Treatment groups for this population were defined according to the treatment assignment at randomization. Missing post-Baseline values and rescue therapy recipients for all subsequent visits after the initiation date of rescue therapy were imputed as nonresponders. The 95% confidence interval was based on the Clopper-Pearson exact method.
Each evening, the participants assessed their worst level of itch during the past 24 hours on a scale of 0 (no itch) to 10 (worst itch imaginable). The Baseline Itch NRS score was determined by averaging the 7 daily Itch NRS scores before Day 1 (i.e., Day -7 to Day -1). If ≥4 of the 7 days of the daily Itch NRS scores were missing prior to Day 1, then the Baseline Itch NRS score was set to "missing." The by-visit Itch NRS score for postbaseline visits was determined by averaging the 7 daily Itch NRS scores before the visit day. If 4 or more daily Itch NRS scores out of the 7 days before the visit day were missing, the Itch NRS score at the visit was set to missing.
Outcome measures
| Measure |
Placebo
n=37 Participants
On Day 1, participants were randomized to receive matching placebo once daily (QD) and stratified by Investigator's Global Assessment (IGA) score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 15 mg
n=36 Participants
On Day 1, participants were randomized to receive povorcitinib 15 milligrams (mg) QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 45 mg
n=36 Participants
On Day 1, participants were randomized to receive povorcitinib 45 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 75 mg
n=37 Participants
On Day 1, participants were randomized to receive povorcitinib 75 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Placebo to Povorcitinib 75 mg
Participants who received placebo during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Povorcitinib 15 mg to 75 mg
Participants who received povorcitinib 15 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Povorcitinib 45 mg to 75 mg
Participants who received povorcitinib 45 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Povorcitinib 75 mg
Participants who received povorcitinib 75 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for an additional 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving ≥4-point Improvement in Itch Numerical Rating Scale (NRS) Score at Week 16
|
8.1 percentage of participants
Interval 1.7 to 21.9
|
36.1 percentage of participants
Interval 20.8 to 53.8
|
44.4 percentage of participants
Interval 27.9 to 61.9
|
56.8 percentage of participants
Interval 39.5 to 72.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 16Population: ITT Population. Missing post-Baseline values were imputed as non-responders. The 95% confidence interval was based on the Clopper-Pearson exact method.
The IGA for chronic prurigo considers the number of pruriginous lesions, which includes papules, nodules, plaques, umbilicated ulcers, and ulcers, and uses them as an overall severity rating on a scale of 0 to 4. 0: clear; no pruriginous lesions (0 lesions). 1: almost clear; rare palpable pruriginous lesions (approximately 1-5 lesions). 2: mild; few palpable pruriginous lesions (approximately 6-19 lesions). 3: moderate: many palpable pruriginous lesions (approximately 20-100 lesions). 4: severe; abundant palpable pruriginous lesions (over 100 lesions). The IGA-TS is defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline.
Outcome measures
| Measure |
Placebo
n=37 Participants
On Day 1, participants were randomized to receive matching placebo once daily (QD) and stratified by Investigator's Global Assessment (IGA) score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 15 mg
n=36 Participants
On Day 1, participants were randomized to receive povorcitinib 15 milligrams (mg) QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 45 mg
n=36 Participants
On Day 1, participants were randomized to receive povorcitinib 45 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 75 mg
n=37 Participants
On Day 1, participants were randomized to receive povorcitinib 75 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Placebo to Povorcitinib 75 mg
Participants who received placebo during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Povorcitinib 15 mg to 75 mg
Participants who received povorcitinib 15 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Povorcitinib 45 mg to 75 mg
Participants who received povorcitinib 45 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Povorcitinib 75 mg
Participants who received povorcitinib 75 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for an additional 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) (IGA Score of 0 or 1 With a ≥2-grade Improvement From Baseline) at Week 16
|
5.4 percentage of participants
Interval 0.7 to 18.2
|
13.9 percentage of participants
Interval 4.7 to 29.5
|
30.6 percentage of participants
Interval 16.3 to 48.1
|
48.6 percentage of participants
Interval 31.9 to 65.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 122 daysPopulation: ITT Population. The time to a ≥4-point improvement from Baseline in itch NRS score was estimated using the Kaplan-Meier method. The confidence interval for the median time to a ≥4-point improvement from Baseline was calculated using the method of Brookmeyer and Crowley. Only participants with available data were analyzed.
Each evening, the participants assessed their worst level of itch during the past 24 hours on a scale of 0 (no itch) to 10 (worst itch imaginable). The Baseline Itch NRS score was determined by averaging the 7 daily Itch NRS scores before Day 1 (i.e., Day -7 to Day -1). If ≥4 of the 7 days of the daily Itch NRS scores were missing prior to Day 1, then the Baseline Itch NRS score was set to "missing." The by-visit Itch NRS score for postbaseline visits was determined by averaging the 7 daily Itch NRS scores before the visit day. If 4 or more daily Itch NRS scores out of the 7 days before the visit day were missing, the Itch NRS score at the visit was set to missing.
Outcome measures
| Measure |
Placebo
n=36 Participants
On Day 1, participants were randomized to receive matching placebo once daily (QD) and stratified by Investigator's Global Assessment (IGA) score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 15 mg
n=35 Participants
On Day 1, participants were randomized to receive povorcitinib 15 milligrams (mg) QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 45 mg
n=34 Participants
On Day 1, participants were randomized to receive povorcitinib 45 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 75 mg
n=36 Participants
On Day 1, participants were randomized to receive povorcitinib 75 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Placebo to Povorcitinib 75 mg
Participants who received placebo during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Povorcitinib 15 mg to 75 mg
Participants who received povorcitinib 15 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Povorcitinib 45 mg to 75 mg
Participants who received povorcitinib 45 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Povorcitinib 75 mg
Participants who received povorcitinib 75 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for an additional 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
|---|---|---|---|---|---|---|---|---|
|
Time to ≥4-point Improvement From Baseline in Itch NRS Score
|
NA days
The median and the upper and lower limits of the confidence interval were not estimable because too few participants achieved a ≥4-point improvement from Baseline in itch NRS score.
|
58.0 days
Interval 16.0 to
The upper limit of the confidence interval was not estimable because too few participants achieved a ≥4-point improvement from Baseline in itch NRS score.
|
35.0 days
Interval 21.0 to
The upper limit of the confidence interval was not estimable because too few participants achieved a ≥4-point improvement from Baseline in itch NRS score.
|
19.0 days
Interval 13.0 to 47.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 152 daysPopulation: Safety Population: all participants who received at least 1 dose of study drug. Treatment groups for this population were determined according to the actual treatment the participant received on Day 1.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug up to 30 days after the last dose of study drug.
Outcome measures
| Measure |
Placebo
n=37 Participants
On Day 1, participants were randomized to receive matching placebo once daily (QD) and stratified by Investigator's Global Assessment (IGA) score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 15 mg
n=36 Participants
On Day 1, participants were randomized to receive povorcitinib 15 milligrams (mg) QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 45 mg
n=35 Participants
On Day 1, participants were randomized to receive povorcitinib 45 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 75 mg
n=37 Participants
On Day 1, participants were randomized to receive povorcitinib 75 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Placebo to Povorcitinib 75 mg
Participants who received placebo during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Povorcitinib 15 mg to 75 mg
Participants who received povorcitinib 15 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Povorcitinib 45 mg to 75 mg
Participants who received povorcitinib 45 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Povorcitinib 75 mg
Participants who received povorcitinib 75 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for an additional 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
|---|---|---|---|---|---|---|---|---|
|
PC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
|
20 Participants
|
20 Participants
|
25 Participants
|
28 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 152 daysPopulation: Safety Population
A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug up to 30 days after the last dose of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events version 5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and serious adverse event (SAE) reported during the study and assigned it to 1 of the following categories. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Outcome measures
| Measure |
Placebo
n=37 Participants
On Day 1, participants were randomized to receive matching placebo once daily (QD) and stratified by Investigator's Global Assessment (IGA) score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 15 mg
n=36 Participants
On Day 1, participants were randomized to receive povorcitinib 15 milligrams (mg) QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 45 mg
n=35 Participants
On Day 1, participants were randomized to receive povorcitinib 45 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 75 mg
n=37 Participants
On Day 1, participants were randomized to receive povorcitinib 75 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Placebo to Povorcitinib 75 mg
Participants who received placebo during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Povorcitinib 15 mg to 75 mg
Participants who received povorcitinib 15 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Povorcitinib 45 mg to 75 mg
Participants who received povorcitinib 45 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Povorcitinib 75 mg
Participants who received povorcitinib 75 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for an additional 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
|---|---|---|---|---|---|---|---|---|
|
PC Period: Number of Participants With Any ≥Grade 3 TEAE
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 215 daysPopulation: Extension Evaluable Population: all participants who received at least 1 dose of povorcitinib during the Extension Period
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug up to 30 days after the last dose of study drug.
Outcome measures
| Measure |
Placebo
n=1 Participants
On Day 1, participants were randomized to receive matching placebo once daily (QD) and stratified by Investigator's Global Assessment (IGA) score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 15 mg
n=4 Participants
On Day 1, participants were randomized to receive povorcitinib 15 milligrams (mg) QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 45 mg
n=8 Participants
On Day 1, participants were randomized to receive povorcitinib 45 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 75 mg
n=15 Participants
On Day 1, participants were randomized to receive povorcitinib 75 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Placebo to Povorcitinib 75 mg
n=30 Participants
Participants who received placebo during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Povorcitinib 15 mg to 75 mg
n=25 Participants
Participants who received povorcitinib 15 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Povorcitinib 45 mg to 75 mg
n=23 Participants
Participants who received povorcitinib 45 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Povorcitinib 75 mg
n=18 Participants
Participants who received povorcitinib 75 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for an additional 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
|---|---|---|---|---|---|---|---|---|
|
Extension Period: Number of Participants With Any TEAE
|
0 Participants
|
3 Participants
|
5 Participants
|
7 Participants
|
20 Participants
|
19 Participants
|
16 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: up to 215 daysPopulation: Extension Evaluable Population
A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug up to 30 days after the last dose of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events version 5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and serious adverse event (SAE) reported during the study and assigned it to 1 of the following categories. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Outcome measures
| Measure |
Placebo
n=1 Participants
On Day 1, participants were randomized to receive matching placebo once daily (QD) and stratified by Investigator's Global Assessment (IGA) score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 15 mg
n=4 Participants
On Day 1, participants were randomized to receive povorcitinib 15 milligrams (mg) QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 45 mg
n=8 Participants
On Day 1, participants were randomized to receive povorcitinib 45 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 75 mg
n=15 Participants
On Day 1, participants were randomized to receive povorcitinib 75 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Placebo to Povorcitinib 75 mg
n=30 Participants
Participants who received placebo during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Povorcitinib 15 mg to 75 mg
n=25 Participants
Participants who received povorcitinib 15 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Povorcitinib 45 mg to 75 mg
n=23 Participants
Participants who received povorcitinib 45 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Povorcitinib 75 mg
n=18 Participants
Participants who received povorcitinib 75 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for an additional 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
|---|---|---|---|---|---|---|---|---|
|
Extension Period: Number of Participants With Any ≥Grade 3 TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Povorcitinib 15 mg
Serious events: 2 serious events
Other events: 17 other events
Deaths: 1 deaths
Povorcitinib 45 mg
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
Povorcitinib 75 mg
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo to Povorcitinib 45 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Povorcitinib 15 mg to 45 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Povorcitinib 45 mg to 45 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Povorcitinib 75 mg to 45 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo to Povorcitinib 75 mg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Povorcitinib 15 mg to 75 mg
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Povorcitinib 45 mg to 75 mg
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Povorcitinib 75 mg to 75 mg
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=37 participants at risk
On Day 1, participants were randomized to receive matching placebo once daily (QD) and stratified by Investigator's Global Assessment (IGA) score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 15 mg
n=36 participants at risk
On Day 1, participants were randomized to receive povorcitinib 15 milligrams (mg) QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 45 mg
n=35 participants at risk
On Day 1, participants were randomized to receive povorcitinib 45 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 75 mg
n=37 participants at risk
On Day 1, participants were randomized to receive povorcitinib 75 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Placebo to Povorcitinib 45 mg
n=1 participants at risk
Participants who received placebo during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch Numerical Rating Scale (NRS) score and Investigator's Global Assessment-Treatment Success (IGA-TS) who did not receive rescue therapy during the placebo-controlled period.
|
Povorcitinib 15 mg to 45 mg
n=4 participants at risk
Participants who received povorcitinib 15 mg during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch NRS score and IGA-TS who did not receive rescue therapy during the placebo-controlled period.
|
Povorcitinib 45 mg to 45 mg
n=8 participants at risk
Participants who received povorcitinib 45 mg during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for an additional 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch NRS score and IGA-TS who did not receive rescue therapy during the placebo-controlled period.
|
Povorcitinib 75 mg to 45 mg
n=15 participants at risk
Participants who received povorcitinib 75 mg during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch NRS score and IGA-TS who did not receive rescue therapy during the placebo-controlled period.
|
Placebo to Povorcitinib 75 mg
n=30 participants at risk
Participants who received placebo during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Povorcitinib 15 mg to 75 mg
n=25 participants at risk
Participants who received povorcitinib 15 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Povorcitinib 45 mg to 75 mg
n=23 participants at risk
Participants who received povorcitinib 45 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Povorcitinib 75 mg to 75 mg
n=18 participants at risk
Participants who received povorcitinib 75 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for an additional 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
General disorders
Death
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.8%
1/36 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Mastitis
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
4.0%
1/25 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.8%
1/36 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Placebo
n=37 participants at risk
On Day 1, participants were randomized to receive matching placebo once daily (QD) and stratified by Investigator's Global Assessment (IGA) score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 15 mg
n=36 participants at risk
On Day 1, participants were randomized to receive povorcitinib 15 milligrams (mg) QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 45 mg
n=35 participants at risk
On Day 1, participants were randomized to receive povorcitinib 45 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Povorcitinib 75 mg
n=37 participants at risk
On Day 1, participants were randomized to receive povorcitinib 75 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
|
Placebo to Povorcitinib 45 mg
n=1 participants at risk
Participants who received placebo during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch Numerical Rating Scale (NRS) score and Investigator's Global Assessment-Treatment Success (IGA-TS) who did not receive rescue therapy during the placebo-controlled period.
|
Povorcitinib 15 mg to 45 mg
n=4 participants at risk
Participants who received povorcitinib 15 mg during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch NRS score and IGA-TS who did not receive rescue therapy during the placebo-controlled period.
|
Povorcitinib 45 mg to 45 mg
n=8 participants at risk
Participants who received povorcitinib 45 mg during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for an additional 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch NRS score and IGA-TS who did not receive rescue therapy during the placebo-controlled period.
|
Povorcitinib 75 mg to 45 mg
n=15 participants at risk
Participants who received povorcitinib 75 mg during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch NRS score and IGA-TS who did not receive rescue therapy during the placebo-controlled period.
|
Placebo to Povorcitinib 75 mg
n=30 participants at risk
Participants who received placebo during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Povorcitinib 15 mg to 75 mg
n=25 participants at risk
Participants who received povorcitinib 15 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Povorcitinib 45 mg to 75 mg
n=23 participants at risk
Participants who received povorcitinib 45 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
Povorcitinib 75 mg to 75 mg
n=18 participants at risk
Participants who received povorcitinib 75 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for an additional 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Investigations
Aspergillus test positive
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
2/36 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
8.6%
3/35 • Number of events 3 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
8.0%
2/25 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
8.7%
2/23 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Eye disorders
Blepharitis
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.4%
2/37 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
3.3%
1/30 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
4.0%
1/25 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
17.4%
4/23 • Number of events 4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.4%
2/37 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
6.7%
2/30 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
COVID-19
|
5.4%
2/37 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
2/36 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
3.3%
1/30 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
8.0%
2/25 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
4.0%
1/25 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.8%
1/36 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.8%
1/36 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cystitis
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
8.7%
2/23 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
13.3%
2/15 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
3.3%
1/30 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.4%
2/37 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.8%
1/36 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
4.0%
1/25 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
6.7%
2/30 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Eyelid folliculitis
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
13.9%
5/36 • Number of events 7 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
8.6%
3/35 • Number of events 3 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.4%
2/37 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
6.7%
2/30 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
4.0%
1/25 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.8%
1/36 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
8.7%
2/23 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
6.7%
2/30 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
4.0%
1/25 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
10.8%
4/37 • Number of events 4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
20.0%
5/25 • Number of events 6 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
16.7%
3/18 • Number of events 4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
16.7%
6/36 • Number of events 7 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
17.1%
6/35 • Number of events 8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
3.3%
1/30 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
4.0%
1/25 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.4%
2/37 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
8.0%
2/25 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
3.3%
1/30 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
4.0%
1/25 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Joint capsule rupture
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Lichen myxoedematosus
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Loose tooth
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
8.1%
3/37 • Number of events 4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
2/36 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • Number of events 4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
13.5%
5/37 • Number of events 5 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
25.0%
2/8 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
10.0%
3/30 • Number of events 3 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
12.0%
3/25 • Number of events 4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
11.1%
4/36 • Number of events 5 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.8%
1/36 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.4%
2/37 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 3 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
3.3%
1/30 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
4.0%
1/25 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
8.1%
3/37 • Number of events 3 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
3.3%
1/30 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
12.0%
3/25 • Number of events 3 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.8%
1/36 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
3.3%
1/30 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
3.3%
1/30 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
8.0%
2/25 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Perioral dermatitis
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
8.0%
2/25 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.4%
2/37 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Skin candida
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Skin infection
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.4%
2/37 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
4.0%
1/25 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
6.7%
2/30 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
6.7%
2/30 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Trichoglossia
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.8%
1/36 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
3.3%
1/30 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
4.0%
1/25 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/18 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Investigations
Weight increased
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
10.0%
3/30 • Number of events 3 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.8%
1/36 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Abscess
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Conjunctivitis
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.8%
1/36 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
3.3%
1/30 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Investigations
Myelocyte count increased
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Investigations
Platelet count increased
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Seizure
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/25 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
2.7%
1/37 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/36 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/37 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/15 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/30 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
4.0%
1/25 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER