Trial Outcomes & Findings for Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis (NCT NCT02015520)
NCT ID: NCT02015520
Last Updated: 2021-05-12
Results Overview
DAS28-CRP describes severity of rheumatoid arthritis. The components of the joint count assessment are shoulder, elbow, wrist, metacarpophalangeal joints 1 through 5, proximal interphalangeal joints 1 through 5, and the knee joints on the right and left sides, whereby the number of affected joints, tender and swollen, respectively, are counted. The formula used to calculate the score is: DAS28-CRP=0.56 \\times \\sqrt{TEN28} + 0.28 \\times \\sqrt{SW28} + 0.36 \\times \\ln(CRP+1) + 0.014 \\times SA+0.96 with: TEN28: number of joints with tenderness upon touching SW28: number of swollen joints CRP: C-reactive Protein SA: subjective assessment of disease activity by the patient during the preceding 7 days on a scale between 0 and 100 ("0":no activity, "100": highest activity possible). DAS-CRP score range is 0.49 to 9.07 A DAS-CRP value \>5.1 corresponds to a high disease activity A DAS-28 reduction by 0.6 represents a moderate improvement. A reduction \>1.2 represents a major improvement
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
143 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2021-05-12
Participant Flow
Participant milestones
| Measure |
Placebo + Methotrexate (MTX)
Placebo (5% dextrose) subcutaneous (SC) administration once every 4 weeks for 12 weeks plus background methotrexate (MTX)
|
Clazakizumab (1 mg) + MTX
Clazakizumab (1 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
Clazakizumab (5 mg) + MTX
Clazakizumab (5 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
Clazakizumab (25 mg) + MTX
Clazakizumab (25 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
21
|
42
|
40
|
|
Overall Study
COMPLETED
|
35
|
17
|
35
|
36
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
7
|
4
|
Reasons for withdrawal
| Measure |
Placebo + Methotrexate (MTX)
Placebo (5% dextrose) subcutaneous (SC) administration once every 4 weeks for 12 weeks plus background methotrexate (MTX)
|
Clazakizumab (1 mg) + MTX
Clazakizumab (1 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
Clazakizumab (5 mg) + MTX
Clazakizumab (5 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
Clazakizumab (25 mg) + MTX
Clazakizumab (25 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
3
|
2
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Overall Study
Subject Request to Discontinue Study Treatment
|
1
|
1
|
2
|
1
|
|
Overall Study
Subject no Longer Meets Study Criteria
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Placebo + Methotrexate (MTX)
n=40 Participants
Placebo (5% dextrose) subcutaneous (SC) administration once every 4 weeks for 12 weeks plus background methotrexate (MTX)
|
Clazakizumab (1 mg) + MTX
n=21 Participants
Clazakizumab (1 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
Clazakizumab (5 mg) + MTX
n=42 Participants
Clazakizumab (5 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
Clazakizumab (25 mg) + MTX
n=40 Participants
Clazakizumab (25 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
Total
n=143 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
114 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Age, Continuous
|
54.4 years
STANDARD_DEVIATION 11.21 • n=5 Participants
|
55.8 years
STANDARD_DEVIATION 11.20 • n=7 Participants
|
53.4 years
STANDARD_DEVIATION 13.75 • n=5 Participants
|
52.6 years
STANDARD_DEVIATION 13.21 • n=4 Participants
|
53.8 years
STANDARD_DEVIATION 12.48 • n=21 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
121 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
0 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Region of Enrollment
Argentina
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
6 participants
n=4 Participants
|
18 participants
n=21 Participants
|
|
Region of Enrollment
Hungary
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
5 participants
n=4 Participants
|
22 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
9 participants
n=4 Participants
|
38 participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
4 participants
n=4 Participants
|
16 participants
n=21 Participants
|
|
Region of Enrollment
Italy
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Region of Enrollment
Mexico
|
8 participants
n=5 Participants
|
1 participants
n=7 Participants
|
8 participants
n=5 Participants
|
12 participants
n=4 Participants
|
29 participants
n=21 Participants
|
|
Region of Enrollment
South Africa
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
12 participants
n=21 Participants
|
|
Region of Enrollment
France
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Modified Intent-to-Treat (mITT) Analysis Population: All randomized subjects who received at least 1 dose of the study medication.
DAS28-CRP describes severity of rheumatoid arthritis. The components of the joint count assessment are shoulder, elbow, wrist, metacarpophalangeal joints 1 through 5, proximal interphalangeal joints 1 through 5, and the knee joints on the right and left sides, whereby the number of affected joints, tender and swollen, respectively, are counted. The formula used to calculate the score is: DAS28-CRP=0.56 \\times \\sqrt{TEN28} + 0.28 \\times \\sqrt{SW28} + 0.36 \\times \\ln(CRP+1) + 0.014 \\times SA+0.96 with: TEN28: number of joints with tenderness upon touching SW28: number of swollen joints CRP: C-reactive Protein SA: subjective assessment of disease activity by the patient during the preceding 7 days on a scale between 0 and 100 ("0":no activity, "100": highest activity possible). DAS-CRP score range is 0.49 to 9.07 A DAS-CRP value \>5.1 corresponds to a high disease activity A DAS-28 reduction by 0.6 represents a moderate improvement. A reduction \>1.2 represents a major improvement
Outcome measures
| Measure |
Placebo + Methotrexate (MTX)
n=34 Participants
Placebo (5% dextrose) subcutaneous (SC) administration once every 4 weeks for 12 weeks plus background methotrexate (MTX)
|
Clazakizumab (1 mg) + MTX
n=15 Participants
Clazakizumab (1 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
Clazakizumab (5 mg) + MTX
n=35 Participants
Clazakizumab (5 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
Clazakizumab (25 mg) + MTX
n=37 Participants
Clazakizumab (25 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score in 28 Joints - C-reactive Protein (DAS28-CRP) at Week 12
|
-0.75 score on a scale
Standard Error 0.22
|
-1.10 score on a scale
Standard Error 0.33
|
-2.10 score on a scale
Standard Error 0.22
|
-2.43 score on a scale
Standard Error 0.22
|
SECONDARY outcome
Timeframe: At week 12Population: mITT
The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
Outcome measures
| Measure |
Placebo + Methotrexate (MTX)
n=40 Participants
Placebo (5% dextrose) subcutaneous (SC) administration once every 4 weeks for 12 weeks plus background methotrexate (MTX)
|
Clazakizumab (1 mg) + MTX
n=21 Participants
Clazakizumab (1 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
Clazakizumab (5 mg) + MTX
n=42 Participants
Clazakizumab (5 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
Clazakizumab (25 mg) + MTX
n=40 Participants
Clazakizumab (25 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
|---|---|---|---|---|
|
American College of Rheumatology (ACR) 20/50/70 Response Rates
ARC20 responders
|
27.5 percentage of responders
|
14.3 percentage of responders
|
50.0 percentage of responders
|
47.5 percentage of responders
|
|
American College of Rheumatology (ACR) 20/50/70 Response Rates
ARC50 responders
|
7.5 percentage of responders
|
14.3 percentage of responders
|
21.4 percentage of responders
|
22.5 percentage of responders
|
|
American College of Rheumatology (ACR) 20/50/70 Response Rates
ARC70 responders
|
2.5 percentage of responders
|
4.8 percentage of responders
|
9.5 percentage of responders
|
15.0 percentage of responders
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: mITT
CDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (SCJ) (0-28) and tender joint count (TJC) (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity. The CDAI has a range from 0 to 76. CDAI \<= 2.8 = Remission CDAI \> 2.8 and \<= 10 = Low Disease Activity CDAI \> 10 and \<= 22 = Moderate Disease Activity CDAI \> 22 = High Disease Activity
Outcome measures
| Measure |
Placebo + Methotrexate (MTX)
n=32 Participants
Placebo (5% dextrose) subcutaneous (SC) administration once every 4 weeks for 12 weeks plus background methotrexate (MTX)
|
Clazakizumab (1 mg) + MTX
n=14 Participants
Clazakizumab (1 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
Clazakizumab (5 mg) + MTX
n=36 Participants
Clazakizumab (5 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
Clazakizumab (25 mg) + MTX
n=37 Participants
Clazakizumab (25 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
|---|---|---|---|---|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Week 12
|
-9.9 score on a scale
Standard Error 2.656
|
-12.8 score on a scale
Standard Error 3.961
|
-17.4 score on a scale
Standard Error 2.545
|
-21.6 score on a scale
Standard Error 2.539
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: mITT
SDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (0-28) and tender joint count (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity and C-reactive protein (0-10). The SDAI has a range from 0 to 86. 0.0 - 3.3 = Remission 3.4 - 11.0 = Low Activity 11.1 - 26.0 = Moderate Activity 26.1 - 86.0 = High Activity
Outcome measures
| Measure |
Placebo + Methotrexate (MTX)
n=32 Participants
Placebo (5% dextrose) subcutaneous (SC) administration once every 4 weeks for 12 weeks plus background methotrexate (MTX)
|
Clazakizumab (1 mg) + MTX
n=14 Participants
Clazakizumab (1 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
Clazakizumab (5 mg) + MTX
n=35 Participants
Clazakizumab (5 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
Clazakizumab (25 mg) + MTX
n=37 Participants
Clazakizumab (25 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
|---|---|---|---|---|
|
Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 12
|
-9.68 score on a scale
Standard Error 2.6846
|
-13.08 score on a scale
Standard Error 4.0011
|
-20.15 score on a scale
Standard Error 2.5928
|
-24.02 score on a scale
Standard Error 2.5677
|
SECONDARY outcome
Timeframe: At week 12Population: mITT
Boolean-based definition: At any time point, a patient must satisfy all of the following: TJC ≤1 (0-28) SJC ≤1 (0-28) CRP ≤1 mg/dl Patient Global Assessment ≤1 (on a 0-10 scale)
Outcome measures
| Measure |
Placebo + Methotrexate (MTX)
n=40 Participants
Placebo (5% dextrose) subcutaneous (SC) administration once every 4 weeks for 12 weeks plus background methotrexate (MTX)
|
Clazakizumab (1 mg) + MTX
n=21 Participants
Clazakizumab (1 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
Clazakizumab (5 mg) + MTX
n=42 Participants
Clazakizumab (5 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
Clazakizumab (25 mg) + MTX
n=40 Participants
Clazakizumab (25 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
|---|---|---|---|---|
|
Boolean Remission at Week 12
|
5.0 percentage of participants
|
4.8 percentage of participants
|
2.4 percentage of participants
|
5.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: mITT
Patients report the amount of difficulty they have in performing 8 categories. Each category is scored on a scale ranging from 0 (performed without any difficulty) to 3 (cannot be done at all). The HAQ-DI is then calculated by summing the scores and dividing by the number of categories answered. Total score is between 0-3.0. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment. The HAQ-DI cannot be calculated if the subject does not have scores for at least 6 categories. A response was defined as a subject with a reduction from baseline in HAQ-DI of at least 0.22.
Outcome measures
| Measure |
Placebo + Methotrexate (MTX)
n=35 Participants
Placebo (5% dextrose) subcutaneous (SC) administration once every 4 weeks for 12 weeks plus background methotrexate (MTX)
|
Clazakizumab (1 mg) + MTX
n=16 Participants
Clazakizumab (1 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
Clazakizumab (5 mg) + MTX
n=36 Participants
Clazakizumab (5 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
Clazakizumab (25 mg) + MTX
n=36 Participants
Clazakizumab (25 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
|---|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 12
|
-0.25 score on a scale
Standard Error 0.0906
|
-0.09 score on a scale
Standard Error 0.1307
|
-0.31 score on a scale
Standard Error 0.0889
|
-0.46 score on a scale
Standard Error 0.0905
|
SECONDARY outcome
Timeframe: At week 12Population: mITT
DAS28- ESR = Disease Activity Scores 28 based on erythrocyte sedimentation rate. A DAS28-ESR below 2.6 is interpreted as remission.
Outcome measures
| Measure |
Placebo + Methotrexate (MTX)
n=40 Participants
Placebo (5% dextrose) subcutaneous (SC) administration once every 4 weeks for 12 weeks plus background methotrexate (MTX)
|
Clazakizumab (1 mg) + MTX
n=21 Participants
Clazakizumab (1 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
Clazakizumab (5 mg) + MTX
n=42 Participants
Clazakizumab (5 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
Clazakizumab (25 mg) + MTX
n=40 Participants
Clazakizumab (25 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
|---|---|---|---|---|
|
Percent of Participants With a DAS28-Erythrocyte Sedimentation Rate (ESR) <2.6
|
2.5 percentage of participants
|
4.8 percentage of participants
|
7.1 percentage of participants
|
15.0 percentage of participants
|
SECONDARY outcome
Timeframe: At week 12Population: mITT
DAS28-CRP = Disease Activity Scores 28 based on C Reactive Protein. A DAS28-CRP below 2.6 is interpreted as remission.
Outcome measures
| Measure |
Placebo + Methotrexate (MTX)
n=40 Participants
Placebo (5% dextrose) subcutaneous (SC) administration once every 4 weeks for 12 weeks plus background methotrexate (MTX)
|
Clazakizumab (1 mg) + MTX
n=21 Participants
Clazakizumab (1 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
Clazakizumab (5 mg) + MTX
n=42 Participants
Clazakizumab (5 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
Clazakizumab (25 mg) + MTX
n=40 Participants
Clazakizumab (25 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
|---|---|---|---|---|
|
Percent of Participants With a DAS28-C Reactive Protein (CRP) <2.6
|
5.0 percentage of participants
|
9.5 percentage of participants
|
14.3 percentage of participants
|
15.0 percentage of participants
|
Adverse Events
Placebo + Methotrexate (MTX)
Serious events: 1 serious events
Other events: 14 other events
Deaths: 1 deaths
Clazakizumab (1 mg) + MTX
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Clazakizumab (5 mg) + MTX
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Clazakizumab (25 mg) + MTX
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo + Methotrexate (MTX)
n=40 participants at risk
Placebo (5% dextrose) subcutaneous (SC) administration once every 4 weeks for 12 weeks plus background methotrexate (MTX)
|
Clazakizumab (1 mg) + MTX
n=21 participants at risk
Clazakizumab (1 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
Clazakizumab (5 mg) + MTX
n=42 participants at risk
Clazakizumab (5 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
Clazakizumab (25 mg) + MTX
n=40 participants at risk
Clazakizumab (25 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
|---|---|---|---|---|
|
General disorders
SUDDEN DEATH
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
Other adverse events
| Measure |
Placebo + Methotrexate (MTX)
n=40 participants at risk
Placebo (5% dextrose) subcutaneous (SC) administration once every 4 weeks for 12 weeks plus background methotrexate (MTX)
|
Clazakizumab (1 mg) + MTX
n=21 participants at risk
Clazakizumab (1 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
Clazakizumab (5 mg) + MTX
n=42 participants at risk
Clazakizumab (5 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
Clazakizumab (25 mg) + MTX
n=40 participants at risk
Clazakizumab (25 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
|
|---|---|---|---|---|
|
Infections and infestations
NASOPHARYNGITIS
|
7.5%
3/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
4.8%
1/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
4.8%
2/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
4.8%
1/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
SINUSITIS
|
5.0%
2/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
General disorders
FATIGUE
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
4.8%
1/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
4.8%
2/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
General disorders
INJECTION SITE REACTION
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
7.5%
3/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
General disorders
INJECTION SITE RASH
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
4.8%
1/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
DIARRHOEA
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
4.8%
2/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
5.0%
2/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
4.8%
1/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
DYSLIPIDAEMIA
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
5.0%
2/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
4.8%
1/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
4.8%
2/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
5.0%
2/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
DIZZINESS
|
5.0%
2/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
7.5%
3/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
7.5%
3/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
CONJUNCTIVITIS
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
4.8%
2/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
ORAL HERPES
|
5.0%
2/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
EAR INFECTION
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
LABYRINTHITIS
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
SKIN CANDIDA
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
TOOTH ABSCESS
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
TOOTH INFECTION
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
VULVOVAGINAL MYCOTIC INFECTION
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
JOINT INJURY
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
SKIN ABRASION
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
4.8%
1/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
4.8%
1/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Investigations
BLOOD CHOLESTEROL INCREASED
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Investigations
BLOOD UREA INCREASED
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Investigations
LOW DENSITY LIPOPROTEIN INCREASED
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Investigations
NEUTROPHIL COUNT INCREASED
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
HEADACHE
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
TENSION HEADACHE
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
TREMOR
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
EOSINOPHILIA
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
4.8%
2/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
RASH VESICULAR
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
SKIN HYPERPIGMENTATION
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
4.8%
1/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
THROAT IRRITATION
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
4.8%
2/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
HEPATIC STEATOSIS
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Ear and labyrinth disorders
EAR PAIN
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Ear and labyrinth disorders
TINNITUS
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Vascular disorders
HYPOTENSION
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Vascular disorders
SECONDARY HYPERTENSION
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Eye disorders
EYE PAIN
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Immune system disorders
SEASONAL ALLERGY
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
VULVOVAGINAL DISCOMFORT
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
General disorders
AXILLARY PAIN
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
General disorders
DRUG INTOLERANCE
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
4.8%
1/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
General disorders
INJECTION SITE BRUISING
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
4.8%
1/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
General disorders
INJECTION SITE PRURITUS
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
General disorders
INJECTION SITE VESICLES
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
General disorders
PYREXIA
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
General disorders
VACCINATION SITE REACTION
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
CONSTIPATION
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
4.8%
2/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
ANAL FISSURE
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
DENTAL CARIES
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
GASTRITIS
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
IRRITABLE BOWEL SYNDROME
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
TEMPOROMANDIBULAR JOINT SYNDROME
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
2.4%
1/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
TENOSYNOVITIS
|
2.5%
1/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/21 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/42 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
0.00%
0/40 • Up to 12 weeks for each participant
As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place