Trial Outcomes & Findings for A Study of the Safety and Efficacy of Ustekinumab in Adolescent Patients With Psoriasis (CADMUS) (NCT NCT01090427)
NCT ID: NCT01090427
Last Updated: 2015-01-29
Results Overview
The PGA documents the physician's assessment of the participant's psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 or 1 at Week 12 in each treatment group.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
110 participants
Primary outcome timeframe
Week 12
Results posted on
2015-01-29
Participant Flow
A total of 110 volunteers from 10 countries were randomized and treated in this study.
A total of 110 participants started and completed the first period in the study (ie, controlled period \[CP\] and entered the 2nd period (ie, After the Controlled Period \[after CP\]); however, only 101 of the 110 participants completed the 2nd period (after CP) of the study.
Participant milestones
| Measure |
Placebo (CP)
Controlled period (Week 0-12) - Placebo Subcutaneous (SC) injections at Week 0 and 4.
|
Ustekinumab Half-Standard Dosage (CP)
Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.375 mg/kg for participants with weight \<= 60kg, 22.5 mg for participants with weight \> 60 to \<= 100kg, and 45 mg for participants with weight \> 100kg.
|
Ustekinumab Standard Dosage (CP)
Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.75 mg/kg for participants with weight \<= 60kg, 45 mg for participants with weight \> 60 to \<= 100kg, and 90 mg for participants with weight \> 100kg.
|
Placebo -> Ustekinumab Half-Standard Dosage (After CP)
After Controlled period (Week 12-60) - participants receiving Placebo at Weeks 0 and 4 -\> receiving Ustekinumab Half-Standard Dosage at Week 12 and 16 then q12w with the last dose at Week 40.
|
Placebo -> Ustekinumab Standard Dosage (After CP)
After Controlled period (Week 12-60) - participants receiving Placebo at Weeks 0 and 4 -\> receiving Ustekinumab Standard Dosage at Week 12 and 16 then q12wk with last dose at Week 40.
|
Ustekinumab Half-Standard Dosage (After CP)
After Controlled period (Week 12-60) - participants receiving Ustekinumab Half-Standard Dosage at Weeks 0 and 4 -\> receiving Ustekinumab Half-Standard Dosage q12wk with the last dose at Week 40.
|
Ustekinumab Standard Dosage (After CP)
After Controlled period (Week 12-60) - participants receiving Ustekinumab Standard Dosage at Weeks 0 and 4 -\> receiving Ustekinumab Standard Dosage q12wk with last dose at Week 40.
|
|---|---|---|---|---|---|---|---|
|
Controlled Period
STARTED
|
37
|
37
|
36
|
0
|
0
|
0
|
0
|
|
Controlled Period
COMPLETED
|
37
|
37
|
36
|
0
|
0
|
0
|
0
|
|
Controlled Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
After Controlled Period
STARTED
|
0
|
0
|
0
|
19
|
18
|
37
|
36
|
|
After Controlled Period
COMPLETED
|
0
|
0
|
0
|
17
|
18
|
32
|
34
|
|
After Controlled Period
NOT COMPLETED
|
0
|
0
|
0
|
2
|
0
|
5
|
2
|
Reasons for withdrawal
| Measure |
Placebo (CP)
Controlled period (Week 0-12) - Placebo Subcutaneous (SC) injections at Week 0 and 4.
|
Ustekinumab Half-Standard Dosage (CP)
Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.375 mg/kg for participants with weight \<= 60kg, 22.5 mg for participants with weight \> 60 to \<= 100kg, and 45 mg for participants with weight \> 100kg.
|
Ustekinumab Standard Dosage (CP)
Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.75 mg/kg for participants with weight \<= 60kg, 45 mg for participants with weight \> 60 to \<= 100kg, and 90 mg for participants with weight \> 100kg.
|
Placebo -> Ustekinumab Half-Standard Dosage (After CP)
After Controlled period (Week 12-60) - participants receiving Placebo at Weeks 0 and 4 -\> receiving Ustekinumab Half-Standard Dosage at Week 12 and 16 then q12w with the last dose at Week 40.
|
Placebo -> Ustekinumab Standard Dosage (After CP)
After Controlled period (Week 12-60) - participants receiving Placebo at Weeks 0 and 4 -\> receiving Ustekinumab Standard Dosage at Week 12 and 16 then q12wk with last dose at Week 40.
|
Ustekinumab Half-Standard Dosage (After CP)
After Controlled period (Week 12-60) - participants receiving Ustekinumab Half-Standard Dosage at Weeks 0 and 4 -\> receiving Ustekinumab Half-Standard Dosage q12wk with the last dose at Week 40.
|
Ustekinumab Standard Dosage (After CP)
After Controlled period (Week 12-60) - participants receiving Ustekinumab Standard Dosage at Weeks 0 and 4 -\> receiving Ustekinumab Standard Dosage q12wk with last dose at Week 40.
|
|---|---|---|---|---|---|---|---|
|
After Controlled Period
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
After Controlled Period
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
3
|
2
|
|
After Controlled Period
Adverse Event
|
0
|
0
|
0
|
2
|
0
|
1
|
0
|
Baseline Characteristics
A Study of the Safety and Efficacy of Ustekinumab in Adolescent Patients With Psoriasis (CADMUS)
Baseline characteristics by cohort
| Measure |
Placebo
n=37 Participants
Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
|
Ustekinumab Half-Standard Dosage
n=37 Participants
Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
|
Ustekinumab Standard Dosage
n=36 Participants
Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
15.6 years
STANDARD_DEVIATION 1.46 • n=5 Participants
|
15.1 years
STANDARD_DEVIATION 1.7 • n=7 Participants
|
14.8 years
STANDARD_DEVIATION 1.73 • n=5 Participants
|
15.2 years
STANDARD_DEVIATION 1.65 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Age
12-15 years
|
15 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
55 participants
n=4 Participants
|
|
Age
16-17 years
|
22 participants
n=5 Participants
|
17 participants
n=7 Participants
|
16 participants
n=5 Participants
|
55 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: The primary efficacy analysis was performed using the all randomized subjects analysis set defined as the population of all participants who were randomized to any treatment group.
The PGA documents the physician's assessment of the participant's psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 or 1 at Week 12 in each treatment group.
Outcome measures
| Measure |
Placebo
n=37 Participants
Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
|
Ustekinumab Half-Standard Dosage
n=37 Participants
Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
|
Ustekinumab Standard Dosage
n=36 Participants
Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
|
|---|---|---|---|
|
The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12
|
5.4 Percentage of Participants
|
67.6 Percentage of Participants
|
69.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 12Population: The analysis of the PASI 75 response at Week 12 was performed using the all randomized subjects analysis set defined as the population of all participants who were randomized to any treatment group.
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating worse disease. A PASI 75 response is defined as a equal to or greater than (=\>) 75% improvement in PASI score from baseline. The table below shows the percentage of participants who achieved a PASI 75 response at Week 12 in each treatment group.
Outcome measures
| Measure |
Placebo
n=37 Participants
Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
|
Ustekinumab Half-Standard Dosage
n=37 Participants
Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
|
Ustekinumab Standard Dosage
n=36 Participants
Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
|
|---|---|---|---|
|
The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 75 Response at Week 12
|
10.8 Percentage of Participants
|
78.4 Percentage of Participants
|
80.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: Evaluable participants for CDLQI are the subsets of all randomized participants with evaluable outcome measurements.
The CDLQI is a dermatology-specific quality of life instrument designed to assess the impact of the disease on a child's quality of life. The CDLQI, a 10-item questionnaire has 4 items response options and a recall period of 1 week. In addition to evaluating overall quality of life, the CDLQI can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, leisure, School or holidays, personal relationships, sleep, and treatment. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0; the higher the score, the greater impairment in quality of life. The table below shows the mean change in CDLQI score from baseline at Week 12 for each treatment group.
Outcome measures
| Measure |
Placebo
n=32 Participants
Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
|
Ustekinumab Half-Standard Dosage
n=35 Participants
Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
|
Ustekinumab Standard Dosage
n=32 Participants
Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
|
|---|---|---|---|
|
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups
|
-1.5 Scores on a scale
Standard Deviation 3.18
|
-5.6 Scores on a scale
Standard Deviation 6.43
|
-6.7 Scores on a scale
Standard Deviation 5.63
|
SECONDARY outcome
Timeframe: Week 12Population: The analysis of the PASI 90 response at Week 12 was performed using the all randomized subjects analysis set defined as the population of all participants who were randomized to any treatment group.
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating worse disease. The table below shows the percentage of participants who achieved a PASI 90 response defined as achieving a greater than or equal to (≥) 90% improvement in PASI score from baseline.
Outcome measures
| Measure |
Placebo
n=37 Participants
Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
|
Ustekinumab Half-Standard Dosage
n=37 Participants
Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
|
Ustekinumab Standard Dosage
n=36 Participants
Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
|
|---|---|---|---|
|
The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups
|
5.4 Percentage of Participants
|
54.1 Percentage of Participants
|
61.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements.
The PGA documents the physician's assessment of the participant's psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 and the percentage of participants who achieved a PGA score of 0, 1, or 2 at Week 12 in each treatment group.
Outcome measures
| Measure |
Placebo
n=37 Participants
Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
|
Ustekinumab Half-Standard Dosage
n=37 Participants
Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
|
Ustekinumab Standard Dosage
n=36 Participants
Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
|
|---|---|---|---|
|
The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) and PGA Score of Mild or Better (<=2) at Week 12
PGA of 0
|
2.7 Percentage of participants
|
32.4 Percentage of participants
|
47.2 Percentage of participants
|
|
The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) and PGA Score of Mild or Better (<=2) at Week 12
PGA of 0, 1, or 2
|
32.4 Percentage of participants
|
81.1 Percentage of participants
|
83.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements.
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). The table below shows the percentage of participants in each treatment group who were PASI 50 responders at Week 12 defined as participants who achieved a greater than or equal to (\>=) 50% improvement in PASI score from baseline as well as the percentage of participants with a PASI score of 0.
Outcome measures
| Measure |
Placebo
n=37 Participants
Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
|
Ustekinumab Half-Standard Dosage
n=37 Participants
Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
|
Ustekinumab Standard Dosage
n=36 Participants
Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
|
|---|---|---|---|
|
The Percentage of Participants Who Were PASI 50 Responders and the Percentage of Participants With a PASI Score of 0 at Week 12
PASI 50 responders
|
29.7 Percentage of participants
|
81.1 Percentage of participants
|
88.9 Percentage of participants
|
|
The Percentage of Participants Who Were PASI 50 Responders and the Percentage of Participants With a PASI Score of 0 at Week 12
Participants with PASI score of 0
|
2.7 Percentage of participants
|
21.6 Percentage of participants
|
38.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements available.
The PedsQL is a general health-related quality of life measure developed for use in children and adolescent populations. The Generic Core Scale contains 23 items and is comprised of 4 domains: physical, social, emotional, and school functioning. Each domain can be scored independently. Additionally, a Psychosocial Health and Physical Health Summary Score can be calculated as well as a total score. The measure distinguishes between healthy children and children with acute and chronic health conditions and disease severity within a chronic health condition. The measure is applicable for healthy school and community populations, as well as with pediatric populations with acute and chronic health conditions and has versions for both parent and teen report. Scores range from 0 to 100, and higher scores indicate better health related quality of life.
Outcome measures
| Measure |
Placebo
n=36 Participants
Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
|
Ustekinumab Half-Standard Dosage
n=36 Participants
Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
|
Ustekinumab Standard Dosage
n=36 Participants
Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
|
|---|---|---|---|
|
The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12
PedsQL Total scale score
|
3.35 Scores on a scale
Standard Deviation 10.044
|
10.81 Scores on a scale
Standard Deviation 12.882
|
8.03 Scores on a scale
Standard Deviation 10.436
|
|
The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12
PedsQL Psychosocial health summary score
|
3.66 Scores on a scale
Standard Deviation 9.610
|
12.13 Scores on a scale
Standard Deviation 15.153
|
8.43 Scores on a scale
Standard Deviation 11.812
|
|
The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12
PedsQL Physical health summary score
|
2.86 Scores on a scale
Standard Deviation 12.860
|
8.33 Scores on a scale
Standard Deviation 11.378
|
7.29 Scores on a scale
Standard Deviation 13.446
|
SECONDARY outcome
Timeframe: Week 12Population: Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements. In addition, this analysis was limited to participants with a CDLQI of 0 or 1 at baseline.
Outcome measures
| Measure |
Placebo
n=30 Participants
Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
|
Ustekinumab Half-Standard Dosage
n=31 Participants
Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
|
Ustekinumab Standard Dosage
n=30 Participants
Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
|
|---|---|---|---|
|
The Percentage of Participants With CDLQI Scores of 0 or 1 at Week 12 for Randomized Participants With a Baseline CDLQI Score > 1
|
13.3 Percentage of participants
|
38.7 Percentage of participants
|
56.7 Percentage of participants
|
Adverse Events
Placebo (CP)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Ustekinumab Half-Standard Dosage (CP)
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Ustekinumab Standard Dosage (CP)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo -> Ustekinumab Half-Standard Dosage (After CP)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo -> Ustekinumab Standard Dosage (After CP)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Ustekinumab Half-Standard Dosage (After CP)
Serious events: 5 serious events
Other events: 28 other events
Deaths: 0 deaths
Ustekinumab Standard Dosage (After CP)
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (CP)
n=37 participants at risk
Controlled period (Week 0-12) - Placebo Subcutaneous (SC) injections at Week 0 and 4.
|
Ustekinumab Half-Standard Dosage (CP)
n=37 participants at risk
Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.375 mg/kg for participants with weight \<= 60kg, 22.5 mg for participants with weight \> 60 to \<= 100kg, and 45 mg for participants with weight \> 100kg.
|
Ustekinumab Standard Dosage (CP)
n=36 participants at risk
Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.75 mg/kg for participants with weight \<= 60kg, 45 mg for participants with weight \> 60 to \<= 100kg, and 90 mg for participants with weight \> 100kg.
|
Placebo -> Ustekinumab Half-Standard Dosage (After CP)
n=19 participants at risk
After Controlled period (Week 12-60) - participants receiving Placebo at Weeks 0 and 4 -\> receiving Ustekinumab Half-Standard Dosage at Week 12 and 16 then q12w with the last dose at Week 40.
|
Placebo -> Ustekinumab Standard Dosage (After CP)
n=18 participants at risk
After Controlled period (Week 12-60) - participants receiving Placebo at Weeks 0 and 4 -\> receiving Ustekinumab Standard Dosage at Week 12 and 16 then q12wk with last dose at Week 40.
|
Ustekinumab Half-Standard Dosage (After CP)
n=37 participants at risk
After Controlled period (Week 12-60) - participants receiving Ustekinumab Half-Standard Dosage at Weeks 0 and 4 -\> receiving Ustekinumab Half-Standard Dosage q12wk with the last dose at Week 40.
|
Ustekinumab Standard Dosage (After CP)
n=36 participants at risk
After Controlled period (Week 12-60) - participants receiving Ustekinumab Standard Dosage at Weeks 0 and 4 -\> receiving Ustekinumab Standard Dosage q12wk with last dose at Week 40.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Infections and infestations
Ear Infection
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.8%
1/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
Other adverse events
| Measure |
Placebo (CP)
n=37 participants at risk
Controlled period (Week 0-12) - Placebo Subcutaneous (SC) injections at Week 0 and 4.
|
Ustekinumab Half-Standard Dosage (CP)
n=37 participants at risk
Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.375 mg/kg for participants with weight \<= 60kg, 22.5 mg for participants with weight \> 60 to \<= 100kg, and 45 mg for participants with weight \> 100kg.
|
Ustekinumab Standard Dosage (CP)
n=36 participants at risk
Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.75 mg/kg for participants with weight \<= 60kg, 45 mg for participants with weight \> 60 to \<= 100kg, and 90 mg for participants with weight \> 100kg.
|
Placebo -> Ustekinumab Half-Standard Dosage (After CP)
n=19 participants at risk
After Controlled period (Week 12-60) - participants receiving Placebo at Weeks 0 and 4 -\> receiving Ustekinumab Half-Standard Dosage at Week 12 and 16 then q12w with the last dose at Week 40.
|
Placebo -> Ustekinumab Standard Dosage (After CP)
n=18 participants at risk
After Controlled period (Week 12-60) - participants receiving Placebo at Weeks 0 and 4 -\> receiving Ustekinumab Standard Dosage at Week 12 and 16 then q12wk with last dose at Week 40.
|
Ustekinumab Half-Standard Dosage (After CP)
n=37 participants at risk
After Controlled period (Week 12-60) - participants receiving Ustekinumab Half-Standard Dosage at Weeks 0 and 4 -\> receiving Ustekinumab Half-Standard Dosage q12wk with the last dose at Week 40.
|
Ustekinumab Standard Dosage (After CP)
n=36 participants at risk
After Controlled period (Week 12-60) - participants receiving Ustekinumab Standard Dosage at Weeks 0 and 4 -\> receiving Ustekinumab Standard Dosage q12wk with last dose at Week 40.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Laryngitis
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
1/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.8%
1/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Infections and infestations
Nasopharyngitis
|
27.0%
10/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
13.5%
5/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.8%
1/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
26.3%
5/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
55.6%
10/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
29.7%
11/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
30.6%
11/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Infections and infestations
Otitis Externa
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
8.1%
3/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.8%
1/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
1/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.4%
2/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
2/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.8%
1/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
2/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
1/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.4%
2/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
2/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.4%
2/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
1/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Blood and lymphatic system disorders
Monocytosis
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Eye disorders
Blepharitis
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Eye disorders
Eye Pruritus
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
1/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.8%
1/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
8.1%
3/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
2/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
1/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
2/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
2/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
1/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.8%
1/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
1/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Gastrointestinal disorders
Lip Oedema
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
8.1%
3/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.8%
1/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Gastrointestinal disorders
Tooth Deposit
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Gastrointestinal disorders
Tooth Impacted
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
1/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
General disorders
Fatigue
|
5.4%
2/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.8%
1/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
General disorders
Oedema Peripheral
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
1/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
General disorders
Pyrexia
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.8%
1/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Infections and infestations
Bacterial Rhinitis
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
1/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.8%
1/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Infections and infestations
Body Tinea
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
1/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Infections and infestations
Bronchitis
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.8%
1/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.8%
1/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Infections and infestations
Gastroenteritis
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.8%
1/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Infections and infestations
Herpes Simplex
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
1/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Infections and infestations
Influenza
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.8%
1/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
1/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
2/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Infections and infestations
Toxoplasmosis
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.4%
2/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
8.3%
3/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
10.5%
2/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
16.7%
3/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
10.8%
4/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
8.3%
3/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
1/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.8%
1/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Injury, poisoning and procedural complications
Skin Injury
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
1/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.8%
1/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Investigations
Haematocrit Decreased
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Investigations
Haemoglobin Decreased
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Investigations
Lymph Node Palpable
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
1/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
11.1%
2/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
1/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.4%
2/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
2/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic Arthropathy
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
1/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
1/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.4%
2/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Papilloma
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
11.1%
2/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Nervous system disorders
Headache
|
5.4%
2/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
10.8%
4/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
8.3%
3/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
10.5%
2/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
16.7%
3/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
24.3%
9/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
2/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Nervous system disorders
Migraine
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
1/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Psychiatric disorders
Depression
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
1/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
2/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
8.3%
3/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.8%
1/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.8%
1/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
8.1%
3/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.8%
1/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
1/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
1/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.8%
1/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
15.8%
3/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
8.1%
3/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
10.5%
2/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-Airway Cough Syndrome
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
1/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
1/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.8%
1/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
1/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.7%
1/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.8%
1/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.4%
2/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
5.4%
2/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.6%
1/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
8.1%
3/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
2.8%
1/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
5.3%
1/19 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/18 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/37 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
0.00%
0/36 • Through Week 60
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Generally, the only disclosure restriction on the PI is that the sponsor has 60 days to review results communications prior to public release and can embargo communications regarding trial results for a period that does not exceed 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER