Trial Outcomes & Findings for A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With Eosinophilic Esophagitis (NCT NCT04682639)
NCT ID: NCT04682639
Last Updated: 2024-05-06
Results Overview
Eosinophils was counted in the areas of greatest eosinophil density. Counts were reported as the number of eosinophils/high power field (eos/hpf) and multiple hpfs analyzed until the PEC was clearly identified after taking into account all biopsies from all esophageal levels.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
108 participants
Primary outcome timeframe
Baseline, Week 16
Results posted on
2024-05-06
Participant Flow
The study consisted of a Double-Blind treatment period (24 weeks) and an Open Label Extension (OLE) period (28 weeks). Participants who were in the placebo group during the Double-Blind treatment period were re-randomized to etrasimod 1 milligram (mg) or etrasimod 2 mg at entry into the Open Label Extension period.
A total of 262 participants were screened in the study. Out of 262, 154 participants failed screening and 108 participants were randomized and treated.
Participant milestones
| Measure |
Experimental: Etrasimod 2 mg
Participants received etrasimod 2 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
Experimental: Etrasimod 1 mg
Participants received etrasimod 1 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
Placebo Then Etrasimod Any Dose
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 1 or 2 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
OLE: Placebo Then Etrasimod 2 mg
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 2 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
OLE: Placebo Then Etrasimod 1 mg
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 1 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
|---|---|---|---|---|---|
|
Double-Blind Treatment Period (24 Weeks)
STARTED
|
41
|
39
|
28
|
0
|
0
|
|
Double-Blind Treatment Period (24 Weeks)
COMPLETED
|
30
|
31
|
24
|
0
|
0
|
|
Double-Blind Treatment Period (24 Weeks)
NOT COMPLETED
|
11
|
8
|
4
|
0
|
0
|
|
OLE Period (28 Weeks)
STARTED
|
30
|
31
|
0
|
12
|
12
|
|
OLE Period (28 Weeks)
COMPLETED
|
21
|
24
|
0
|
11
|
10
|
|
OLE Period (28 Weeks)
NOT COMPLETED
|
9
|
7
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Experimental: Etrasimod 2 mg
Participants received etrasimod 2 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
Experimental: Etrasimod 1 mg
Participants received etrasimod 1 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
Placebo Then Etrasimod Any Dose
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 1 or 2 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
OLE: Placebo Then Etrasimod 2 mg
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 2 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
OLE: Placebo Then Etrasimod 1 mg
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 1 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
|---|---|---|---|---|---|
|
Double-Blind Treatment Period (24 Weeks)
Adverse Event
|
1
|
0
|
1
|
0
|
0
|
|
Double-Blind Treatment Period (24 Weeks)
Withdrawal by Subject
|
5
|
5
|
2
|
0
|
0
|
|
Double-Blind Treatment Period (24 Weeks)
Lost to Follow-up
|
2
|
1
|
0
|
0
|
0
|
|
Double-Blind Treatment Period (24 Weeks)
Pregnancy
|
0
|
1
|
0
|
0
|
0
|
|
Double-Blind Treatment Period (24 Weeks)
Non-compliance
|
2
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment Period (24 Weeks)
Lack of Efficacy
|
1
|
1
|
1
|
0
|
0
|
|
OLE Period (28 Weeks)
Non-compliance
|
1
|
0
|
0
|
0
|
1
|
|
OLE Period (28 Weeks)
Other
|
1
|
2
|
0
|
0
|
1
|
|
OLE Period (28 Weeks)
Lack of Efficacy
|
2
|
1
|
0
|
0
|
0
|
|
OLE Period (28 Weeks)
Lost to Follow-up
|
1
|
1
|
0
|
0
|
0
|
|
OLE Period (28 Weeks)
Withdrawal by Subject
|
1
|
3
|
0
|
0
|
0
|
|
OLE Period (28 Weeks)
Adverse Event
|
3
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With Eosinophilic Esophagitis
Baseline characteristics by cohort
| Measure |
Experimental: Etrasimod 2 mg
n=41 Participants
Participants received etrasimod 2 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
Experimental: Etrasimod 1 mg
n=39 Participants
Participants received etrasimod 1 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
Placebo Then Etrasimod Any Dose
n=28 Participants
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 1 or 2 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35.6 Years
STANDARD_DEVIATION 9.80 • n=5 Participants
|
39.9 Years
STANDARD_DEVIATION 12.87 • n=7 Participants
|
39.1 Years
STANDARD_DEVIATION 11.65 • n=5 Participants
|
38.1 Years
STANDARD_DEVIATION 11.52 • n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: The Full Analysis Set (FAS) will consist of all randomized participants in the Double-Blind Treatment Period who received at least 1 dose of study treatment. Here, "Number of participants analyzed" signifies number of participants evaluable for this outcome measure.
Eosinophils was counted in the areas of greatest eosinophil density. Counts were reported as the number of eosinophils/high power field (eos/hpf) and multiple hpfs analyzed until the PEC was clearly identified after taking into account all biopsies from all esophageal levels.
Outcome measures
| Measure |
Experimental: Etrasimod 2 mg
n=33 Participants
Participants received etrasimod 2 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
Experimental: Etrasimod 1 mg
n=35 Participants
Participants received etrasimod 1 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
Placebo Then Etrasimod Any Dose
n=20 Participants
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 1 or 2 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
|---|---|---|---|
|
Percent Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16
|
-58.4 Percent change
Interval -86.21 to -26.25
|
-39.4 Percent change
Interval -71.08 to 78.95
|
-21.5 Percent change
Interval -57.2 to 55.42
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: The FAS will consist of all randomized participants in the Double-Blind Treatment Period who received at least 1 dose of study treatment. Here, "Number of participants analyzed" signifies number of participants evaluable for this outcome measure.
The DSQ was used to measure the frequency and intensity of dysphagia to solid food. DSQ contained 4 questions, all participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). DSQ score = (Sum of points from questions 2+3 in the daily DSQ)×14 days/(Number of diaries reported with non-missing data). DSQ scores can range from 0 to 84, with a higher score indicating worse dysphagia.
Outcome measures
| Measure |
Experimental: Etrasimod 2 mg
n=32 Participants
Participants received etrasimod 2 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
Experimental: Etrasimod 1 mg
n=36 Participants
Participants received etrasimod 1 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
Placebo Then Etrasimod Any Dose
n=24 Participants
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 1 or 2 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
|---|---|---|---|
|
Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Score at Week 16
|
-17.11 Units on a scale
Standard Error 2.247
|
-14.78 Units on a scale
Standard Error 2.166
|
-19.49 Units on a scale
Standard Error 2.602
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: The FAS will consist of all randomized participants in the Double-Blind Treatment Period who received at least 1 dose of study treatment. Here, "Number of participants analyzed" signifies number of participants evaluable for this outcome measure.
Eosinophils was counted in the areas of greatest eosinophil density. Counts were reported as the number of eosinophils/high power field (eos/hpf) and multiple hpfs analyzed until the PEC was clearly identified after taking into account all biopsies from all esophageal levels.
Outcome measures
| Measure |
Experimental: Etrasimod 2 mg
n=33 Participants
Participants received etrasimod 2 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
Experimental: Etrasimod 1 mg
n=35 Participants
Participants received etrasimod 1 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
Placebo Then Etrasimod Any Dose
n=20 Participants
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 1 or 2 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
|---|---|---|---|
|
Absolute Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16
|
-46.3 eos/hpf
Standard Error 17.46
|
-5.7 eos/hpf
Standard Error 16.99
|
8.3 eos/hpf
Standard Error 22.37
|
SECONDARY outcome
Timeframe: Week 16Population: The FAS will consist of all randomized participants in the Double-Blind Treatment Period who received at least 1 dose of study treatment.
Outcome measures
| Measure |
Experimental: Etrasimod 2 mg
n=41 Participants
Participants received etrasimod 2 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
Experimental: Etrasimod 1 mg
n=39 Participants
Participants received etrasimod 1 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
Placebo Then Etrasimod Any Dose
n=28 Participants
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 1 or 2 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
|---|---|---|---|
|
Percentage Of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than (<) 15 Eosinophils/High Power Field (Eos/Hpf) at Week 16
|
22.0 Percentage of participants
|
12.8 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: The FAS will consist of all randomized participants in the Double-Blind Treatment Period who received at least 1 dose of study treatment.
Outcome measures
| Measure |
Experimental: Etrasimod 2 mg
n=41 Participants
Participants received etrasimod 2 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
Experimental: Etrasimod 1 mg
n=39 Participants
Participants received etrasimod 1 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
Placebo Then Etrasimod Any Dose
n=28 Participants
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 1 or 2 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than or Equal to (<=) 6 Eosinophils/High Power Field (Eos/Hpf) at Week 16
|
12.2 Percentage of participants
|
7.7 Percentage of participants
|
0 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, up to Week 24Population: The safety population included all randomized participants who received at least 1 dose of study treatment during the specified treatment period. Here, "Number of participants analyzed" signifies number of participants evaluable for this outcome measure.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AE is defined as an AE that started or worsened in severity on or after the first dose of study treatment. Severity is classified as Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-Threatening, Grade 5: Death Related to AE.
Outcome measures
| Measure |
Experimental: Etrasimod 2 mg
n=29 Participants
Participants received etrasimod 2 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
Experimental: Etrasimod 1 mg
n=27 Participants
Participants received etrasimod 1 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
Placebo Then Etrasimod Any Dose
n=21 Participants
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 1 or 2 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Maximum Severity During 24 Week Double Blind Treatment Period
TEAE: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Maximum Severity During 24 Week Double Blind Treatment Period
TEAE: Grade 1
|
19 Participants
|
15 Participants
|
8 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Maximum Severity During 24 Week Double Blind Treatment Period
TEAE: Grade 2
|
9 Participants
|
12 Participants
|
11 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Maximum Severity During 24 Week Double Blind Treatment Period
TEAE: Grade 3
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Maximum Severity During 24 Week Double Blind Treatment Period
TEAE: Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 24Population: The safety population included all randomized participants who received at least 1 dose of study treatment during the specified treatment period.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of death); new or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 24 weeks after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to etrasimod was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Outcome measures
| Measure |
Experimental: Etrasimod 2 mg
n=41 Participants
Participants received etrasimod 2 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
Experimental: Etrasimod 1 mg
n=39 Participants
Participants received etrasimod 1 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
Placebo Then Etrasimod Any Dose
n=28 Participants
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 1 or 2 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
|---|---|---|---|
|
Number of Participants With Serious TEAEs, TEAEs Leading to Study Treatment Discontinuation, TEAEs Leading to Death and TEAEs of Special Interest During 24 Week Double Blind Treatment Period
Serious TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Serious TEAEs, TEAEs Leading to Study Treatment Discontinuation, TEAEs Leading to Death and TEAEs of Special Interest During 24 Week Double Blind Treatment Period
TEAEs leading to study treatment discontinuation
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Serious TEAEs, TEAEs Leading to Study Treatment Discontinuation, TEAEs Leading to Death and TEAEs of Special Interest During 24 Week Double Blind Treatment Period
TEAEs leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Experimental: Etrasimod 2 mg
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Experimental: Etrasimod 1 mg
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Placebo Then Etrasimod Any Dose
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
OLE: Etrasimod 2 mg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
OLE: Etrasimod 1 mg
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
OLE: Placebo Then Etrasimod 2 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
OLE: Placebo Then Etrasimod 1 mg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental: Etrasimod 2 mg
n=41 participants at risk
Participants received etrasimod 2 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
Experimental: Etrasimod 1 mg
n=39 participants at risk
Participants received etrasimod 1 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
Placebo Then Etrasimod Any Dose
n=28 participants at risk
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 1 or 2 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
OLE: Etrasimod 2 mg
n=30 participants at risk
Participants received etrasimod 2 mg tablet orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
OLE: Etrasimod 1 mg
n=31 participants at risk
Participants received etrasimod 1 mg tablet orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
OLE: Placebo Then Etrasimod 2 mg
n=12 participants at risk
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 2 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
OLE: Placebo Then Etrasimod 1 mg
n=12 participants at risk
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 1 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
Other adverse events
| Measure |
Experimental: Etrasimod 2 mg
n=41 participants at risk
Participants received etrasimod 2 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
Experimental: Etrasimod 1 mg
n=39 participants at risk
Participants received etrasimod 1 mg tablet orally, once daily for 24 weeks in Double-blind treatment and for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
Placebo Then Etrasimod Any Dose
n=28 participants at risk
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 1 or 2 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
OLE: Etrasimod 2 mg
n=30 participants at risk
Participants received etrasimod 2 mg tablet orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
OLE: Etrasimod 1 mg
n=31 participants at risk
Participants received etrasimod 1 mg tablet orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
OLE: Placebo Then Etrasimod 2 mg
n=12 participants at risk
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 2 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
OLE: Placebo Then Etrasimod 1 mg
n=12 participants at risk
Participants received etrasimod matching placebo orally, once daily for 24 weeks in Double-blind treatment and re-randomized to receive etrasimod tablet 1 mg orally, once daily for 28 weeks in OLE period. Participants were then followed up for safety for up to 4 weeks.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
14.6%
6/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
7.7%
3/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
10.7%
3/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
6.7%
2/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.9%
2/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.6%
1/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
5.1%
2/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.6%
1/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Oesophageal food impaction
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
17.9%
5/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
33.3%
4/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.6%
1/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.6%
1/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Eosinophilic oesophagitis
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
10.7%
3/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Gastritis
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.6%
1/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.6%
1/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Food poisoning
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Odynophagia
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Swollen tongue
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Bile acid malabsorption
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.6%
1/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.6%
1/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
16.7%
2/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Oesophageal rupture
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.6%
1/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.6%
1/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Infections and infestations
COVID-19
|
9.8%
4/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
10.3%
4/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
21.4%
6/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
6.7%
2/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
16.1%
5/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Infections and infestations
Nasopharyngitis
|
7.3%
3/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
5.1%
2/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
5.1%
2/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
6.7%
2/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
5.1%
2/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Infections and infestations
Gastroenteritis viral
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Infections and infestations
Influenza
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Infections and infestations
Cellulitis
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Infections and infestations
Diarrhoea infectious
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Infections and infestations
Ear infection
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Infections and infestations
Folliculitis
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Infections and infestations
Sinusitis
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Infections and infestations
Viral infection
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.6%
1/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Nervous system disorders
Dizziness
|
9.8%
4/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
10.3%
4/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.6%
1/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Nervous system disorders
Headache
|
7.3%
3/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
5.1%
2/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.6%
1/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
16.7%
2/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Nervous system disorders
Balance disorder
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Nervous system disorders
Hypoglossal nerve paralysis
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Nervous system disorders
Migraine
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.6%
1/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.6%
1/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Investigations
Alanine aminotransferase increased
|
7.3%
3/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
5.1%
2/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
13.3%
4/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
16.7%
2/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Investigations
Aspartate aminotransferase increased
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
16.7%
2/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Investigations
Blood pressure increased
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Investigations
Heart rate decreased
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Investigations
Liver function test increased
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Investigations
Lymphocyte count decreased
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Investigations
Transaminases increased
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Investigations
White blood cell count decreased
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Investigations
Helicobacter test positive
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Investigations
Pulmonary function test decreased
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.6%
1/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Eye disorders
Blepharitis
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Eye disorders
Cataract
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Eye disorders
Dry eye
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Eye disorders
Eye irritation
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Eye disorders
Hypermetropia
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Eye disorders
Photopsia
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Eye disorders
Retinal degeneration
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Eye disorders
Visual field defect
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Eye disorders
Visual impairment
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
6.5%
2/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Eye disorders
Meibomian gland dysfunction
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
General disorders
Fatigue
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
General disorders
Influenza like illness
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
General disorders
Pyrexia
|
4.9%
2/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
7.1%
2/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
General disorders
Chest discomfort
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
7.1%
2/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
General disorders
Chest pain
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
General disorders
Chills
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
General disorders
Pain
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
5.1%
2/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.6%
1/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Femoroacetabular impingement
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.6%
1/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.9%
2/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
7.1%
2/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
6.7%
2/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
5.1%
2/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
7.1%
2/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.9%
2/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.6%
1/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.6%
1/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal spasm
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.6%
1/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Injury, poisoning and procedural complications
Limb fracture
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.6%
1/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Psychiatric disorders
Insomnia
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
5.1%
2/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Skin and subcutaneous tissue disorders
Excessive granulation tissue
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.6%
1/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Cardiac disorders
Bradycardia
|
4.9%
2/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.6%
1/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Renal and urinary disorders
Urinary hesitation
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Reproductive system and breast disorders
Breast discomfort
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
2.6%
1/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Psychiatric disorders
Stress
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.2%
1/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Investigations
Pulmonary function test abnormal
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
8.3%
1/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Acquired oesophageal web
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.3%
1/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
2.4%
1/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/41 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/39 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
3.6%
1/28 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/30 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/31 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
0.00%
0/12 • Baseline up to a maximum of 61 weeks (35 days screening period, 24 weeks of double-blind treatment period, 28 weeks of active extended treatment, and 4 weeks of follow-up period)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. All participants who receive any of the study intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER